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FDA 510(k)

TREBAY PARTIAL RECTRANGULAR HEADS, MORETZ CAM, INCUS/STAPEDIAL JOINT & STRAIGHT INCUS STRUT

K-Number: K954517 · 1995-10-27

Decision Date1995-10-27
Product CodeETB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

TREBAY PARTIAL RECTRANGULAR HEADS, MORETZ CAM, INCUS/STAPEDIAL JOINT & STRAIGHT INCUS STRUT is the device name listed in this FDA 510(k) record. The listed applicant is Trebay Medical Corp.. It received FDA 510(k) clearance on 1995-10-27 under 510(k) number K954517. 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 TREBAY PARTIAL RECTRANGULAR HEADS, MORETZ CAM, INCUS/STAPEDIAL JOINT & STRAIGHT INCUS STRUT?

TREBAY PARTIAL RECTRANGULAR HEADS, MORETZ CAM, INCUS/STAPEDIAL JOINT & STRAIGHT INCUS STRUT is a medical device that received FDA 510(k) clearance on 1995-10-27. The listed applicant is Trebay Medical Corp.. The 510(k) number is K954517.

When did TREBAY PARTIAL RECTRANGULAR HEADS, MORETZ CAM, INCUS/STAPEDIAL JOINT & STRAIGHT INCUS STRUT receive FDA 510(k) clearance?

TREBAY PARTIAL RECTRANGULAR HEADS, MORETZ CAM, INCUS/STAPEDIAL JOINT & STRAIGHT INCUS STRUT received FDA 510(k) clearance on 1995-10-27, under 510(k) number K954517.

Who is the listed applicant for TREBAY PARTIAL RECTRANGULAR HEADS, MORETZ CAM, INCUS/STAPEDIAL JOINT & STRAIGHT INCUS STRUT?

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

What is the FDA product code for TREBAY PARTIAL RECTRANGULAR HEADS, MORETZ CAM, INCUS/STAPEDIAL JOINT & STRAIGHT INCUS STRUT?

The FDA product code for TREBAY PARTIAL RECTRANGULAR HEADS, MORETZ CAM, INCUS/STAPEDIAL JOINT & STRAIGHT INCUS STRUT is ETB.

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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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