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FDA 510(k)

SOFT TISSUE SUTURE WASHER/3 HOLE WASHER

K-Number: K910229 · 1991-07-24

ApplicantDepuy, Inc.
Decision Date1991-07-24
Product CodeHTN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SOFT TISSUE SUTURE WASHER/3 HOLE WASHER is the device name listed in this FDA 510(k) record. The listed applicant is Depuy, Inc.. It received FDA 510(k) clearance on 1991-07-24 under 510(k) number K910229. The device is classified under product code HTN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOFT TISSUE SUTURE WASHER/3 HOLE WASHER?

SOFT TISSUE SUTURE WASHER/3 HOLE WASHER is a medical device that received FDA 510(k) clearance on 1991-07-24. The listed applicant is Depuy, Inc.. The 510(k) number is K910229.

When did SOFT TISSUE SUTURE WASHER/3 HOLE WASHER receive FDA 510(k) clearance?

SOFT TISSUE SUTURE WASHER/3 HOLE WASHER received FDA 510(k) clearance on 1991-07-24, under 510(k) number K910229.

Who is the listed applicant for SOFT TISSUE SUTURE WASHER/3 HOLE WASHER?

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

What is the FDA product code for SOFT TISSUE SUTURE WASHER/3 HOLE WASHER?

The FDA product code for SOFT TISSUE SUTURE WASHER/3 HOLE WASHER is HTN.

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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.

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