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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gown, Surgical
510(k) Number K241214
Device Name ProPel SG3™ Surgical Gown
Applicant
Standard Textile Co., Inc.
One Knollcrest Dr.
Cincinnati,  OH  45237
Applicant Contact Richard Holbert
Correspondent
RQM+
2790 Mosside Blvd., Suite 800
Monroeville,,  PA  15146
Correspondent Contact Catherine Kang
Regulation Number878.4040
Classification Product Code
FYA  
Date Received04/30/2024
Decision Date 09/10/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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