ComfortGuard Surgical Isolation Gown— 510(k) K210131

Substantially Equivalent

Gri-Alleset, Inc.

FDA 510(k) clearance K210131 for ComfortGuard Surgical Isolation Gown, Substantially Equivalent on 2021-08-26. Applicant: Gri-Alleset, Inc..

Clearance details

Applicant: Gri-Alleset, Inc.
Product code: Code FYC
Advisory panel: General, Plastic Surgery
Date received: 2021-01-19
Decision date: 2021-08-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Flowery Branch, GA, US

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