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FDA 510(k)

BARRIER FABRIC 450 SPECIALTY GOWN

K-Number: K760864 · 1976-11-03

ApplicantSurgikos, Inc.
Decision Date1976-11-03
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BARRIER FABRIC 450 SPECIALTY GOWN is the device name listed in this FDA 510(k) record. The listed applicant is Surgikos, Inc.. It received FDA 510(k) clearance on 1976-11-03 under 510(k) number K760864. 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 BARRIER FABRIC 450 SPECIALTY GOWN?

BARRIER FABRIC 450 SPECIALTY GOWN is a medical device that received FDA 510(k) clearance on 1976-11-03. The listed applicant is Surgikos, Inc.. The 510(k) number is K760864.

When did BARRIER FABRIC 450 SPECIALTY GOWN receive FDA 510(k) clearance?

BARRIER FABRIC 450 SPECIALTY GOWN received FDA 510(k) clearance on 1976-11-03, under 510(k) number K760864.

Who is the listed applicant for BARRIER FABRIC 450 SPECIALTY GOWN?

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

What is the FDA product code for BARRIER FABRIC 450 SPECIALTY GOWN?

The FDA product code for BARRIER FABRIC 450 SPECIALTY GOWN is FYA.

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Other records listing Surgikos, 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.

K875107HEALTH CARE EYE PROTECTIONK874653STERILE SURGICAL SCRUB BRUSHK861441NEUTRALON SURGICAL GLOVESK852870BARRIER SURGICAL GOWNK822535CIDEX*DIALYZER DISINFECTING SOLUTIONK820543BARRIER ANTIMICROBIAL INCISE DRAPE

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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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