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FDA 510(k)

O.R./SURGEONS GOWN, ITEM NO. 4942

K-Number: K921157 · 1993-07-09

ApplicantThe Sewing Source, Inc.
Decision Date1993-07-09
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

O.R./SURGEONS GOWN, ITEM NO. 4942 is the device name listed in this FDA 510(k) record. The listed applicant is The Sewing Source, Inc.. It received FDA 510(k) clearance on 1993-07-09 under 510(k) number K921157. 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 O.R./SURGEONS GOWN, ITEM NO. 4942?

O.R./SURGEONS GOWN, ITEM NO. 4942 is a medical device that received FDA 510(k) clearance on 1993-07-09. The listed applicant is The Sewing Source, Inc.. The 510(k) number is K921157.

When did O.R./SURGEONS GOWN, ITEM NO. 4942 receive FDA 510(k) clearance?

O.R./SURGEONS GOWN, ITEM NO. 4942 received FDA 510(k) clearance on 1993-07-09, under 510(k) number K921157.

Who is the listed applicant for O.R./SURGEONS GOWN, ITEM NO. 4942?

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

What is the FDA product code for O.R./SURGEONS GOWN, ITEM NO. 4942?

The FDA product code for O.R./SURGEONS GOWN, ITEM NO. 4942 is FYA.

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Other records listing The Sewing Source, 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.

K960045ENVIROTEX REUSABLE O.R. WRAPPER AND CUSTOM SURGICAL DRAPEK921158O.R./SURGEONS GOWN, ITEM NO. 4950K921154O.R./SURGEONS GOWN, ITEM NO. 4962K921155O.R./SURGEONS GOWN, ITEM NO. 4962K921156O.R./SURGEONS GOWN, ITEM NO.4941K921151O.R./SURGEONS GOWN, ITEM NO. 4951

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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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