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FDA 510(k)

STERILE SURGEON'S GOWN, MODIFICATION

K-Number: K931144 · 1994-06-10

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

Device Summary

STERILE SURGEON'S GOWN, MODIFICATION 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 K931144. The device is classified under product code FYA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERILE SURGEON'S GOWN, MODIFICATION?

STERILE SURGEON'S GOWN, MODIFICATION 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 K931144.

When did STERILE SURGEON'S GOWN, MODIFICATION receive FDA 510(k) clearance?

STERILE SURGEON'S GOWN, MODIFICATION received FDA 510(k) clearance on 1994-06-10, under 510(k) number K931144.

Who is the listed applicant for STERILE SURGEON'S GOWN, MODIFICATION?

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 STERILE SURGEON'S GOWN, MODIFICATION?

The FDA product code for STERILE SURGEON'S GOWN, MODIFICATION is FYA.

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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, MODIFICATIONK931145NON-STERILE ISOLATION GOWNK931875AUTOCLAVABLE REUSABLE WRAP -- CENTERAL SERVICE USEK931874RECOVERIES AUTOCLAVABLE RESUABLE WRAP -- FAC. USE

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Related Devices (Code: FYA)

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.

K260407Principle & Will ANSI/AAMI PB 70 (Sterile/Non-sterile) Level 3 Surgical Gowns (Reinforced) and Principle & Will ANSI/AMMI PB70 (Sterile/Non-sterile) Level 4 Surgical Gowns/Isolation GownsPrinciple & Will Co., Ltd.K261028Surgical Gown Level2 (S, M, L, XL, XXL, XXXL)Yadu Medical (Henan) Co., Ltd.K261949NYES Tuff Cuff L3 Disposable GownsNew York Embroidery StudioK252575Tuff Cuff™ Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L)New York Embroidery Studio (NYES)K260725BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)Hindernis DE Mexico, S.A.P.I. DE C.V.K253243Cardinal Health™ Poly Reinforced Surgical GownCardinal Health 200, 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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