FDA 510(k)

HYPAFIX POST OPERATIVE DRESSING

K-Number: K850282 · 1985-05-07

Decision Date1985-05-07

Product CodeNAD

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

HYPAFIX POST OPERATIVE DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew, Inc.. It received FDA 510(k) clearance on 1985-05-07 under 510(k) number K850282. The device is classified under product code NAD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYPAFIX POST OPERATIVE DRESSING?

HYPAFIX POST OPERATIVE DRESSING is a medical device that received FDA 510(k) clearance on 1985-05-07. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K850282.

When did HYPAFIX POST OPERATIVE DRESSING receive FDA 510(k) clearance?

HYPAFIX POST OPERATIVE DRESSING received FDA 510(k) clearance on 1985-05-07, under 510(k) number K850282.

Who is the listed applicant for HYPAFIX POST OPERATIVE DRESSING?

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

What is the FDA product code for HYPAFIX POST OPERATIVE DRESSING?

The FDA product code for HYPAFIX POST OPERATIVE DRESSING is NAD.

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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.