FDA 510(k)

MICROMED TOTAL REGULAR AND PARTIAL OFFSET

K-Number: K945106 · 1994-11-22

Decision Date1994-11-22

Product CodeETA

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

MICROMED TOTAL REGULAR AND PARTIAL OFFSET is the device name listed in this FDA 510(k) record. The listed applicant is Micromed Development Corp.. It received FDA 510(k) clearance on 1994-11-22 under 510(k) number K945106. 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 MICROMED TOTAL REGULAR AND PARTIAL OFFSET?

MICROMED TOTAL REGULAR AND PARTIAL OFFSET is a medical device that received FDA 510(k) clearance on 1994-11-22. The listed applicant is Micromed Development Corp.. The 510(k) number is K945106.

When did MICROMED TOTAL REGULAR AND PARTIAL OFFSET receive FDA 510(k) clearance?

MICROMED TOTAL REGULAR AND PARTIAL OFFSET received FDA 510(k) clearance on 1994-11-22, under 510(k) number K945106.

Who is the listed applicant for MICROMED TOTAL REGULAR AND PARTIAL OFFSET?

The FDA 510(k) record lists Micromed Development Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MICROMED TOTAL REGULAR AND PARTIAL OFFSET?

The FDA product code for MICROMED TOTAL REGULAR AND PARTIAL OFFSET is ETA.

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Other records listing Micromed Development Corp. as applicant

K945105POLY/PLATINUM WIRE PISTON K945831DISPOSABLE JOINT ASPIRATION/INJECTION DIAGNOSTIC KIT K945242NERVE MONITOR ELECTRODES/STIMULATOR PROBES K945108POLY PISTON K945107POLY-WIRE PISTON K945104MICROMED PARTIAL REGULAR AND PARTIAL OFFSET

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Related Devices (Code: ETA)

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 GmbH K241269mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total Prosthesis KitMED-EL Elektromedizinische Geräte GmbH K091187GRACE 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 Endoscopy K042503KURZ 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.