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FDA 510(k)

SURGICAL APPAREL

K-Number: K954549 · 1996-04-18

ApplicantGlobal Healthcare, Inc.
Decision Date1996-04-18
Product CodeFYC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGICAL APPAREL is the device name listed in this FDA 510(k) record. The listed applicant is Global Healthcare, Inc.. It received FDA 510(k) clearance on 1996-04-18 under 510(k) number K954549. 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 SURGICAL APPAREL?

SURGICAL APPAREL is a medical device that received FDA 510(k) clearance on 1996-04-18. The listed applicant is Global Healthcare, Inc.. The 510(k) number is K954549.

When did SURGICAL APPAREL receive FDA 510(k) clearance?

SURGICAL APPAREL received FDA 510(k) clearance on 1996-04-18, under 510(k) number K954549.

Who is the listed applicant for SURGICAL APPAREL?

The FDA 510(k) record lists Global Healthcare, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SURGICAL APPAREL?

The FDA product code for SURGICAL APPAREL 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Related PubMed Literature

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.

PMID: 30016835Medical Devices; Exemption From Premarket Notification: Class II Devices; Surgical Apparel. Final order.Federal register ()

Other records listing Global Healthcare, Inc. 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.

K990567GLOBAL HEALTHCARE SELF-SEALING STERILIZATION POUCHK953754GLOBAL HEALTHCARE FACE MASK

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.

K232849Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI 3 Isolation Gown, X-Large, Blue (54311)Owens & Minor (O&M) Halyard, Inc.K230135Copioumed Chemotherapy Isolation GownCopioumed International, Inc.K223467Disposable Isolation GownNanning Tecbod Biological Technology Co., Ltd.K223304Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)Xiamen Probtain Medical Technology Co., Ltd.K223411Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)Xiamen Probtain Medical Techology Co., Ltd.K212717Paneffort AAMI Level 3 Isolation GownPaneffort, LLC

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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