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FDA 510(k)

GOWN, OPERATING, SURGICAL

K-Number: K894284 · 1989-07-14

ApplicantMiroz Industries Co.
Decision Date1989-07-14
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GOWN, OPERATING, SURGICAL is the device name listed in this FDA 510(k) record. The listed applicant is Miroz Industries Co.. It received FDA 510(k) clearance on 1989-07-14 under 510(k) number K894284. 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 GOWN, OPERATING, SURGICAL?

GOWN, OPERATING, SURGICAL is a medical device that received FDA 510(k) clearance on 1989-07-14. The listed applicant is Miroz Industries Co.. The 510(k) number is K894284.

When did GOWN, OPERATING, SURGICAL receive FDA 510(k) clearance?

GOWN, OPERATING, SURGICAL received FDA 510(k) clearance on 1989-07-14, under 510(k) number K894284.

Who is the listed applicant for GOWN, OPERATING, SURGICAL?

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

What is the FDA product code for GOWN, OPERATING, SURGICAL?

The FDA product code for GOWN, OPERATING, SURGICAL is FYA.

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Other records listing Miroz Industries Co. 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.

K894599SHIRT, OPERATING, SURGICAL

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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