FDA 510(k)

OSSICULAR PROSTHESES 4 PARTIAL, 4 TOTAL, 2 CONVERT

K-Number: K885201 · 1989-04-19

Decision Date1989-04-19

Product CodeETA

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

OSSICULAR PROSTHESES 4 PARTIAL, 4 TOTAL, 2 CONVERT is the device name listed in this FDA 510(k) record. The listed applicant is Microbio-Medics, Inc.. It received FDA 510(k) clearance on 1989-04-19 under 510(k) number K885201. 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 OSSICULAR PROSTHESES 4 PARTIAL, 4 TOTAL, 2 CONVERT?

OSSICULAR PROSTHESES 4 PARTIAL, 4 TOTAL, 2 CONVERT is a medical device that received FDA 510(k) clearance on 1989-04-19. The listed applicant is Microbio-Medics, Inc.. The 510(k) number is K885201.

When did OSSICULAR PROSTHESES 4 PARTIAL, 4 TOTAL, 2 CONVERT receive FDA 510(k) clearance?

OSSICULAR PROSTHESES 4 PARTIAL, 4 TOTAL, 2 CONVERT received FDA 510(k) clearance on 1989-04-19, under 510(k) number K885201.

Who is the listed applicant for OSSICULAR PROSTHESES 4 PARTIAL, 4 TOTAL, 2 CONVERT?

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

What is the FDA product code for OSSICULAR PROSTHESES 4 PARTIAL, 4 TOTAL, 2 CONVERT?

The FDA product code for OSSICULAR PROSTHESES 4 PARTIAL, 4 TOTAL, 2 CONVERT is ETA.

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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.