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FDA 510(k)

STERILE BACK GOWN/STAND BACK GOWN(VARIOUS SIZES)

K-Number: K864311 · 1986-11-26

ApplicantClinitech, Inc.
Decision Date1986-11-26
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

STERILE BACK GOWN/STAND BACK GOWN(VARIOUS SIZES) is the device name listed in this FDA 510(k) record. The listed applicant is Clinitech, Inc.. It received FDA 510(k) clearance on 1986-11-26 under 510(k) number K864311. 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 STERILE BACK GOWN/STAND BACK GOWN(VARIOUS SIZES)?

STERILE BACK GOWN/STAND BACK GOWN(VARIOUS SIZES) is a medical device that received FDA 510(k) clearance on 1986-11-26. The listed applicant is Clinitech, Inc.. The 510(k) number is K864311.

When did STERILE BACK GOWN/STAND BACK GOWN(VARIOUS SIZES) receive FDA 510(k) clearance?

STERILE BACK GOWN/STAND BACK GOWN(VARIOUS SIZES) received FDA 510(k) clearance on 1986-11-26, under 510(k) number K864311.

Who is the listed applicant for STERILE BACK GOWN/STAND BACK GOWN(VARIOUS SIZES)?

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

What is the FDA product code for STERILE BACK GOWN/STAND BACK GOWN(VARIOUS SIZES)?

The FDA product code for STERILE BACK GOWN/STAND BACK GOWN(VARIOUS SIZES) is FYA.

Related Clinical Trials

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.

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Other records listing Clinitech, 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.

K896367STERILE SURGICAL DRAPES AND SHEETSK895667STERILE SURGICAL GOWN

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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