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FDA 510(k)

DEPUY STERILE VIEW BARRIER HOOD/GOWN WITH HYTREL

K-Number: K961239 · 1996-09-17

ApplicantDepuy, Inc.
Decision Date1996-09-17
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DEPUY STERILE VIEW BARRIER HOOD/GOWN WITH HYTREL is the device name listed in this FDA 510(k) record. The listed applicant is Depuy, Inc.. It received FDA 510(k) clearance on 1996-09-17 under 510(k) number K961239. The device is classified under product code FYA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEPUY STERILE VIEW BARRIER HOOD/GOWN WITH HYTREL?

DEPUY STERILE VIEW BARRIER HOOD/GOWN WITH HYTREL is a medical device that received FDA 510(k) clearance on 1996-09-17. The listed applicant is Depuy, Inc.. The 510(k) number is K961239.

When did DEPUY STERILE VIEW BARRIER HOOD/GOWN WITH HYTREL receive FDA 510(k) clearance?

DEPUY STERILE VIEW BARRIER HOOD/GOWN WITH HYTREL received FDA 510(k) clearance on 1996-09-17, under 510(k) number K961239.

Who is the listed applicant for DEPUY STERILE VIEW BARRIER HOOD/GOWN WITH HYTREL?

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 DEPUY STERILE VIEW BARRIER HOOD/GOWN WITH HYTREL?

The FDA product code for DEPUY STERILE VIEW BARRIER HOOD/GOWN WITH HYTREL is FYA.

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Related Devices (Code: FYA)

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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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