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FDA 510(k)

BOUNDARY REINFORCED OR GOWN

K-Number: K811958 · 1981-07-27

ApplicantThe Buckeye Cellulose Corp.
Decision Date1981-07-27
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BOUNDARY REINFORCED OR GOWN is the device name listed in this FDA 510(k) record. The listed applicant is The Buckeye Cellulose Corp.. It received FDA 510(k) clearance on 1981-07-27 under 510(k) number K811958. 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 BOUNDARY REINFORCED OR GOWN?

BOUNDARY REINFORCED OR GOWN is a medical device that received FDA 510(k) clearance on 1981-07-27. The listed applicant is The Buckeye Cellulose Corp.. The 510(k) number is K811958.

When did BOUNDARY REINFORCED OR GOWN receive FDA 510(k) clearance?

BOUNDARY REINFORCED OR GOWN received FDA 510(k) clearance on 1981-07-27, under 510(k) number K811958.

Who is the listed applicant for BOUNDARY REINFORCED OR GOWN?

The FDA 510(k) record lists The Buckeye Cellulose Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BOUNDARY REINFORCED OR GOWN?

The FDA product code for BOUNDARY REINFORCED OR GOWN is FYA.

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Other records listing The Buckeye Cellulose Corp. 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.

K822925BOUNDARY SINGLE-USE GOWNSK823173ARRIRM SCRUB BRUSH/SPONGEK821564BOUNDARY PROCESS CHANGEK820758BOUNDARY SINGLE-USE CRANIOTOMY SHEETK820116BOUNDARYK813450BOUNDARY SINGLE-USE DRAPES

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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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