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FDA 510(k)

FAR-EAST BARRIER GOWNS

K-Number: K971702 · 1997-07-08

Decision Date1997-07-08
Product CodeFYC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FAR-EAST BARRIER GOWNS is the device name listed in this FDA 510(k) record. The listed applicant is Far East Science & Technology Development Co., Ltd.. It received FDA 510(k) clearance on 1997-07-08 under 510(k) number K971702. 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 FAR-EAST BARRIER GOWNS?

FAR-EAST BARRIER GOWNS is a medical device that received FDA 510(k) clearance on 1997-07-08. The listed applicant is Far East Science & Technology Development Co., Ltd.. The 510(k) number is K971702.

When did FAR-EAST BARRIER GOWNS receive FDA 510(k) clearance?

FAR-EAST BARRIER GOWNS received FDA 510(k) clearance on 1997-07-08, under 510(k) number K971702.

Who is the listed applicant for FAR-EAST BARRIER GOWNS?

The FDA 510(k) record lists Far East Science & Technology Development Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FAR-EAST BARRIER GOWNS?

The FDA product code for FAR-EAST BARRIER GOWNS is FYC.

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.

Other records listing Far East Science & Technology Development Co., Ltd. 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.

Related Devices (Code: FYC)

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.

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.

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