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FDA 510(k)

MICROTEK MEDICAL SURGICAL GOWN/TOGA

K-Number: K062899 · 2007-01-25

ApplicantMicrotek Medical, Inc.
Decision Date2007-01-25
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MICROTEK MEDICAL SURGICAL GOWN/TOGA is the device name listed in this FDA 510(k) record. The listed applicant is Microtek Medical, Inc.. It received FDA 510(k) clearance on 2007-01-25 under 510(k) number K062899. 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 MICROTEK MEDICAL SURGICAL GOWN/TOGA?

MICROTEK MEDICAL SURGICAL GOWN/TOGA is a medical device that received FDA 510(k) clearance on 2007-01-25. The listed applicant is Microtek Medical, Inc.. The 510(k) number is K062899.

When did MICROTEK MEDICAL SURGICAL GOWN/TOGA receive FDA 510(k) clearance?

MICROTEK MEDICAL SURGICAL GOWN/TOGA received FDA 510(k) clearance on 2007-01-25, under 510(k) number K062899.

Who is the listed applicant for MICROTEK MEDICAL SURGICAL GOWN/TOGA?

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

What is the FDA product code for MICROTEK MEDICAL SURGICAL GOWN/TOGA?

The FDA product code for MICROTEK MEDICAL SURGICAL GOWN/TOGA is FYA.

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Other records listing Microtek Medical, Inc. as applicant

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K110358VENODYNE V810K102971FREEDOMAIRE III SURGICAL HELMET SYSTEM MODEL 10322STKK060200MICROTEK MEDICAL WARMING DRAPEK050322MICROTEK EQUIPMENT DRAPESK022903CHILLBUSTERK020956VIVOSONIC DIANOSTIC ULTRASOUND IMAGING COUPLING MEDIA

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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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