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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gown, Isolation, Surgical
510(k) Number K210131
Device Name ComfortGuard Surgical Isolation Gown
Applicant
Gri-Alleset, Inc.
4142 Industry Way
Flowery Branch,  GA  30542
Applicant Contact Marty D Paugh
Correspondent
Sterilization Consulting Services, LLC
7302 Kinglet Ct.
Katy,  TX  77493
Correspondent Contact Harry L. Shaffer
Regulation Number878.4040
Classification Product Code
FYC  
Date Received01/19/2021
Decision Date 08/26/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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