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FDA 510(k)

GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES, GOLD TOTAL WITH FOUNTIAN HEAD, GOLD PISTON

K-Number: K001404 · 2000-08-08

ApplicantMednet Locator, Inc.
Decision Date2000-08-08
Product CodeETA
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES, GOLD TOTAL WITH FOUNTIAN HEAD, GOLD PISTON is the device name listed in this FDA 510(k) record. The listed applicant is Mednet Locator, Inc.. It received FDA 510(k) clearance on 2000-08-08 under 510(k) number K001404. The device is classified under product code ETA. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES, GOLD TOTAL WITH FOUNTIAN HEAD, GOLD PISTON?

GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES, GOLD TOTAL WITH FOUNTIAN HEAD, GOLD PISTON is a medical device that received FDA 510(k) clearance on 2000-08-08. The listed applicant is Mednet Locator, Inc.. The 510(k) number is K001404.

When did GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES, GOLD TOTAL WITH FOUNTIAN HEAD, GOLD PISTON receive FDA 510(k) clearance?

GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES, GOLD TOTAL WITH FOUNTIAN HEAD, GOLD PISTON received FDA 510(k) clearance on 2000-08-08, under 510(k) number K001404.

Who is the listed applicant for GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES, GOLD TOTAL WITH FOUNTIAN HEAD, GOLD PISTON?

The FDA 510(k) record lists Mednet Locator, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES, GOLD TOTAL WITH FOUNTIAN HEAD, GOLD PISTON?

The FDA product code for GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES, GOLD TOTAL WITH FOUNTIAN HEAD, GOLD PISTON is ETA.

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Other records listing Mednet Locator, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K001406HA/GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESESK974174ULTRABURK972735TOTAL OSSICULAR REPLACEMENT PROSTHESIS (TORP)K972734PARTIAL OSSICULAR REPLACEMENT PROSTHESIS (PORP)K972737CAUSSE PISTONK972126MYRINGOTOMY TUBE

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Related Devices (Code: ETA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260719mGRIP Total Prosthesis (3.00 mm) (58689); mGRIP Total Prosthesis (3.25 mm) (58691); mGRIP Total Prosthesis (3.50 mm) (58693); mGRIP Total Prosthesis (3.75 mm) (58695); mGRIP Total Prosthesis (4.00 mm) (58697); mGRIP Total Prosthesis (4.25 mm) (58699); mGRIP Total Prosthesis (4.50 mm) (58701); mGRIP Total Prosthesis (4.75 mm) (58703); mGRIP Total Prosthesis (5.00 mm) (58705); mGRIP Total Prosthesis (5.50 mm) (58707); mGRIP Total Prosthesis (6.00 mm) (58709); mGRIP Total Prosthesis (6.50MED-EL Elektromedizinische Geräte GmbHK241269mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total Prosthesis KitMED-EL Elektromedizinische Geräte GmbHK091187GRACE DYNAMIC TORPGrace Medical, Inc.K083780SUPERELELASTIC NITINOL PISTON, SUPERELASTIC NITINOL TRIMMABLE PISTON, MODEL SPL03.39/40/41/42 (DETAILS IN 510(K) ANNEX 2Audio Technologies S.R.L.K043375FISCH TITANIUM MIDDLE EAR PROSTHESESKarl Storz EndoscopyK042503KURZ CLIP PISTON MVP, MODEL 1006 711-13/0.4 MM + 1006 761-63/0.6MMHeinz Kurz GmbH Medizintechnik

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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