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FDA 510(k)

SURGICAL GOWNS AND DRAPES

K-Number: K781099 · 1978-08-14

ApplicantConvertors
Decision Date1978-08-14
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGICAL GOWNS AND DRAPES is the device name listed in this FDA 510(k) record. The listed applicant is Convertors. It received FDA 510(k) clearance on 1978-08-14 under 510(k) number K781099. 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 SURGICAL GOWNS AND DRAPES?

SURGICAL GOWNS AND DRAPES is a medical device that received FDA 510(k) clearance on 1978-08-14. The listed applicant is Convertors. The 510(k) number is K781099.

When did SURGICAL GOWNS AND DRAPES receive FDA 510(k) clearance?

SURGICAL GOWNS AND DRAPES received FDA 510(k) clearance on 1978-08-14, under 510(k) number K781099.

Who is the listed applicant for SURGICAL GOWNS AND DRAPES?

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

What is the FDA product code for SURGICAL GOWNS AND DRAPES?

The FDA product code for SURGICAL GOWNS AND DRAPES is FYA.

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Other records listing Convertors 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.

K780627SURG-O-PAK, GOWNS, SHEETS, AND TOWELSK790234DRAPE PACKS, SURGICAL GOWNSK781959SURGICAL GOWNS, SHEETSK781534SURG-O-PAK PREP PADK780169MASK, SURGICALK771929PEDIATRICS GOWN

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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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