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FDA 510(k)

NON-STERILE ISOLATION GOWN

K-Number: K931145 · 1994-06-10

ApplicantAmsco Sterile Recoveries, Inc.
Decision Date1994-06-10
Product CodeFYC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NON-STERILE ISOLATION GOWN is the device name listed in this FDA 510(k) record. The listed applicant is Amsco Sterile Recoveries, Inc.. It received FDA 510(k) clearance on 1994-06-10 under 510(k) number K931145. 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 NON-STERILE ISOLATION GOWN?

NON-STERILE ISOLATION GOWN is a medical device that received FDA 510(k) clearance on 1994-06-10. The listed applicant is Amsco Sterile Recoveries, Inc.. The 510(k) number is K931145.

When did NON-STERILE ISOLATION GOWN receive FDA 510(k) clearance?

NON-STERILE ISOLATION GOWN received FDA 510(k) clearance on 1994-06-10, under 510(k) number K931145.

Who is the listed applicant for NON-STERILE ISOLATION GOWN?

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

What is the FDA product code for NON-STERILE ISOLATION GOWN?

The FDA product code for NON-STERILE ISOLATION GOWN is FYC.

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Other records listing Amsco Sterile Recoveries, 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.

K932522AMSCO STERILE RECOVERIES SURGICAL PACKSK931143AMSCO STERILE RECOVERIES ABSORBENT TOWELSK931146SURGICAL DRAPES, MODIFICATIONK931144STERILE SURGEON'S GOWN, MODIFICATIONK931875AUTOCLAVABLE REUSABLE WRAP -- CENTERAL SERVICE USEK931874RECOVERIES AUTOCLAVABLE RESUABLE WRAP -- FAC. USE

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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

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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