FDA 510(k)

OSSICULAR PROSTHESIS: 8 PARTIAL, 3 TOTAL

K-Number: K884884 · 1989-06-16

ApplicantPorex Technologies Corp. of Georgia

Decision Date1989-06-16

Product CodeETA

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

OSSICULAR PROSTHESIS: 8 PARTIAL, 3 TOTAL is the device name listed in this FDA 510(k) record. The listed applicant is Porex Technologies Corp. of Georgia. It received FDA 510(k) clearance on 1989-06-16 under 510(k) number K884884. 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 PROSTHESIS: 8 PARTIAL, 3 TOTAL?

OSSICULAR PROSTHESIS: 8 PARTIAL, 3 TOTAL is a medical device that received FDA 510(k) clearance on 1989-06-16. The listed applicant is Porex Technologies Corp. of Georgia. The 510(k) number is K884884.

When did OSSICULAR PROSTHESIS: 8 PARTIAL, 3 TOTAL receive FDA 510(k) clearance?

OSSICULAR PROSTHESIS: 8 PARTIAL, 3 TOTAL received FDA 510(k) clearance on 1989-06-16, under 510(k) number K884884.

Who is the listed applicant for OSSICULAR PROSTHESIS: 8 PARTIAL, 3 TOTAL?

The FDA 510(k) record lists Porex Technologies Corp. of Georgia as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OSSICULAR PROSTHESIS: 8 PARTIAL, 3 TOTAL?

The FDA product code for OSSICULAR PROSTHESIS: 8 PARTIAL, 3 TOTAL is ETA.

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Related Devices (Code: ETA)

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Official Source

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