FDA 510(k)

BIOGLASS OSSICULAR RECONSTRUCTION PROSTH

K-Number: K843461 · 1985-01-09

Decision Date1985-01-09

Product CodeETA

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

BIOGLASS OSSICULAR RECONSTRUCTION PROSTH is the device name listed in this FDA 510(k) record. The listed applicant is American Biomaterials Corp.. It received FDA 510(k) clearance on 1985-01-09 under 510(k) number K843461. 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 BIOGLASS OSSICULAR RECONSTRUCTION PROSTH?

BIOGLASS OSSICULAR RECONSTRUCTION PROSTH is a medical device that received FDA 510(k) clearance on 1985-01-09. The listed applicant is American Biomaterials Corp.. The 510(k) number is K843461.

When did BIOGLASS OSSICULAR RECONSTRUCTION PROSTH receive FDA 510(k) clearance?

BIOGLASS OSSICULAR RECONSTRUCTION PROSTH received FDA 510(k) clearance on 1985-01-09, under 510(k) number K843461.

Who is the listed applicant for BIOGLASS OSSICULAR RECONSTRUCTION PROSTH?

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

What is the FDA product code for BIOGLASS OSSICULAR RECONSTRUCTION PROSTH?

The FDA product code for BIOGLASS OSSICULAR RECONSTRUCTION PROSTH is ETA.

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Other records listing American Biomaterials Corp. as applicant

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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

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