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FDA 510(k)

NIOMED BARRIER GOWNS

K-Number: K954747 · 1996-03-06

ApplicantAmerasia Corp.
Decision Date1996-03-06
Product CodeFYC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NIOMED BARRIER GOWNS is the device name listed in this FDA 510(k) record. The listed applicant is Amerasia Corp.. It received FDA 510(k) clearance on 1996-03-06 under 510(k) number K954747. The device is classified under product code FYC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NIOMED BARRIER GOWNS?

NIOMED BARRIER GOWNS is a medical device that received FDA 510(k) clearance on 1996-03-06. The listed applicant is Amerasia Corp.. The 510(k) number is K954747.

When did NIOMED BARRIER GOWNS receive FDA 510(k) clearance?

NIOMED BARRIER GOWNS received FDA 510(k) clearance on 1996-03-06, under 510(k) number K954747.

Who is the listed applicant for NIOMED BARRIER GOWNS?

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

What is the FDA product code for NIOMED BARRIER GOWNS?

The FDA product code for NIOMED BARRIER GOWNS is FYC.

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Other records listing Amerasia Corp. as applicant

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.

K955833NIOMED SURGICAL CAPSK954455NIOMED BOUFFANT CAPSK954454NIOMED SURGICAL HOODK952937NIOMED NON-SKID SHOE COVERSK952897NIOMED SHOE COVERS

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Official Source

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