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FDA 510(k)

PARTIAL OSSICULAR REPLACEMENT PROSTHESIS

K-Number: K964798 · 1997-01-02

ApplicantAnthony D. Prescott
Decision Date1997-01-02
Product CodeETB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

PARTIAL OSSICULAR REPLACEMENT PROSTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Anthony D. Prescott. It received FDA 510(k) clearance on 1997-01-02 under 510(k) number K964798. The device is classified under product code ETB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PARTIAL OSSICULAR REPLACEMENT PROSTHESIS?

PARTIAL OSSICULAR REPLACEMENT PROSTHESIS is a medical device that received FDA 510(k) clearance on 1997-01-02. The listed applicant is Anthony D. Prescott. The 510(k) number is K964798.

When did PARTIAL OSSICULAR REPLACEMENT PROSTHESIS receive FDA 510(k) clearance?

PARTIAL OSSICULAR REPLACEMENT PROSTHESIS received FDA 510(k) clearance on 1997-01-02, under 510(k) number K964798.

Who is the listed applicant for PARTIAL OSSICULAR REPLACEMENT PROSTHESIS?

The FDA 510(k) record lists Anthony D. Prescott as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PARTIAL OSSICULAR REPLACEMENT PROSTHESIS?

The FDA product code for PARTIAL OSSICULAR REPLACEMENT PROSTHESIS is ETB.

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Related Devices (Code: ETB)

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.

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Official Source

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

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