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FDA 510(k)

NIOMED SURGICAL HOOD

K-Number: K954454 · 1996-01-23

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

Device Summary

NIOMED SURGICAL HOOD 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 K954454. 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 SURGICAL HOOD?

NIOMED SURGICAL HOOD 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 K954454.

When did NIOMED SURGICAL HOOD receive FDA 510(k) clearance?

NIOMED SURGICAL HOOD received FDA 510(k) clearance on 1996-01-23, under 510(k) number K954454.

Who is the listed applicant for NIOMED SURGICAL HOOD?

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 SURGICAL HOOD?

The FDA product code for NIOMED SURGICAL HOOD 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 GOWNSK954455NIOMED BOUFFANT CAPSK952937NIOMED 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.K954455NIOMED BOUFFANT CAPSAmerasia 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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