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FDA 510(k)

NIOMED BOUFFANT CAPS

K-Number: K954455 · 1996-01-23

ApplicantAmerasia Corp.
Decision Date1996-01-23
Product CodeFYF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NIOMED BOUFFANT CAPS is the device name listed in this FDA 510(k) record. The listed applicant is Amerasia Corp.. It received FDA 510(k) clearance on 1996-01-23 under 510(k) number K954455. The device is classified under product code FYF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NIOMED BOUFFANT CAPS?

NIOMED BOUFFANT CAPS is a medical device that received FDA 510(k) clearance on 1996-01-23. The listed applicant is Amerasia Corp.. The 510(k) number is K954455.

When did NIOMED BOUFFANT CAPS receive FDA 510(k) clearance?

NIOMED BOUFFANT CAPS received FDA 510(k) clearance on 1996-01-23, under 510(k) number K954455.

Who is the listed applicant for NIOMED BOUFFANT CAPS?

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 BOUFFANT CAPS?

The FDA product code for NIOMED BOUFFANT CAPS is FYF.

Related Clinical Trials

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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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 CAPSK954747NIOMED BARRIER GOWNSK954454NIOMED SURGICAL HOODK952937NIOMED NON-SKID SHOE COVERSK952897NIOMED SHOE COVERS

Related Devices (Code: FYF)

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.

K972227SHOE COVERAmerican Seal Co.K955833NIOMED SURGICAL CAPSAmerasia Corp.K954556SURGICAL CAPThai Disposable Products Co., Ltd.K954454NIOMED SURGICAL HOODAmerasia Corp.K953878BOUFFANT CAPAmerican Threshold Industries, Inc.K953879SURGEON'S CAPAmerican Threshold Industries, Inc.

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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