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FDA 510(k)

ASEP SURGEONS GOWN

K-Number: K914235 · 1992-04-14

ApplicantBaxter Interwoven Offsite
Decision Date1992-04-14
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ASEP SURGEONS GOWN is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Interwoven Offsite. It received FDA 510(k) clearance on 1992-04-14 under 510(k) number K914235. 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 ASEP SURGEONS GOWN?

ASEP SURGEONS GOWN is a medical device that received FDA 510(k) clearance on 1992-04-14. The listed applicant is Baxter Interwoven Offsite. The 510(k) number is K914235.

When did ASEP SURGEONS GOWN receive FDA 510(k) clearance?

ASEP SURGEONS GOWN received FDA 510(k) clearance on 1992-04-14, under 510(k) number K914235.

Who is the listed applicant for ASEP SURGEONS GOWN?

The FDA 510(k) record lists Baxter Interwoven Offsite as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ASEP SURGEONS GOWN?

The FDA product code for ASEP SURGEONS GOWN is FYA.

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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

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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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