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FDA 510(k)

COMPEL 1-PLY SURGICAL GOWNS; COMPEL ISOLATION GOWNS

K-Number: K041653 · 2005-07-01

ApplicantStandard Textile Co., Inc.
Decision Date2005-07-01
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

COMPEL 1-PLY SURGICAL GOWNS; COMPEL ISOLATION GOWNS is the device name listed in this FDA 510(k) record. The listed applicant is Standard Textile Co., Inc.. It received FDA 510(k) clearance on 2005-07-01 under 510(k) number K041653. 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 COMPEL 1-PLY SURGICAL GOWNS; COMPEL ISOLATION GOWNS?

COMPEL 1-PLY SURGICAL GOWNS; COMPEL ISOLATION GOWNS is a medical device that received FDA 510(k) clearance on 2005-07-01. The listed applicant is Standard Textile Co., Inc.. The 510(k) number is K041653.

When did COMPEL 1-PLY SURGICAL GOWNS; COMPEL ISOLATION GOWNS receive FDA 510(k) clearance?

COMPEL 1-PLY SURGICAL GOWNS; COMPEL ISOLATION GOWNS received FDA 510(k) clearance on 2005-07-01, under 510(k) number K041653.

Who is the listed applicant for COMPEL 1-PLY SURGICAL GOWNS; COMPEL ISOLATION GOWNS?

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

What is the FDA product code for COMPEL 1-PLY SURGICAL GOWNS; COMPEL ISOLATION GOWNS?

The FDA product code for COMPEL 1-PLY SURGICAL GOWNS; COMPEL ISOLATION GOWNS is FYA.

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Other records listing Standard Textile Co., 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.

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Related Devices (Code: FYA)

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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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