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FDA 510(k)

MAGNA SURGEONS GOWNS

K-Number: K911508 · 1991-06-17

ApplicantDms Miami, Inc.
Decision Date1991-06-17
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MAGNA SURGEONS GOWNS is the device name listed in this FDA 510(k) record. The listed applicant is Dms Miami, Inc.. It received FDA 510(k) clearance on 1991-06-17 under 510(k) number K911508. 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 MAGNA SURGEONS GOWNS?

MAGNA SURGEONS GOWNS is a medical device that received FDA 510(k) clearance on 1991-06-17. The listed applicant is Dms Miami, Inc.. The 510(k) number is K911508.

When did MAGNA SURGEONS GOWNS receive FDA 510(k) clearance?

MAGNA SURGEONS GOWNS received FDA 510(k) clearance on 1991-06-17, under 510(k) number K911508.

Who is the listed applicant for MAGNA SURGEONS GOWNS?

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

What is the FDA product code for MAGNA SURGEONS GOWNS?

The FDA product code for MAGNA SURGEONS GOWNS 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 Dms Miami, 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.

K911509MAGNA OBSTETRICAL PACKSK911510MAGNA SURGICAL PACKS

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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