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FDA 510(k)

COMPEL E

K-Number: K914839 · 1992-04-02

ApplicantStandard Textile Co., Inc.
Decision Date1992-04-02
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

COMPEL E is the device name listed in this FDA 510(k) record. The listed applicant is Standard Textile Co., Inc.. It received FDA 510(k) clearance on 1992-04-02 under 510(k) number K914839. 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 COMPEL E?

COMPEL E is a medical device that received FDA 510(k) clearance on 1992-04-02. The listed applicant is Standard Textile Co., Inc.. The 510(k) number is K914839.

When did COMPEL E receive FDA 510(k) clearance?

COMPEL E received FDA 510(k) clearance on 1992-04-02, under 510(k) number K914839.

Who is the listed applicant for COMPEL E?

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

What is the FDA product code for COMPEL E?

The FDA product code for COMPEL E is FYA.

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Other records listing Standard Textile Co., Inc. as applicant

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K241214ProPel SG3™ Surgical GownK172207Standard Supreme Sterilization WrapperK162162Barrier Supreme Sterilization WrapperK060181COMPE1 1 -PLY SURGICAL GOWNSK041653COMPEL 1-PLY SURGICAL GOWNS; COMPEL ISOLATION GOWNSK041540COMBOSAFE (EUROPE) AND PROMAX (US) SURGICAL GOWNS

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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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