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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 K012268
Device Name TRIMAX
Applicant
Standard Textile Co., Inc.
One Knollcrest Dr.
Cincinnati,  OH  45237
Applicant Contact BRADLEY J BUSHMAN
Correspondent
Standard Textile Co., Inc.
One Knollcrest Dr.
Cincinnati,  OH  45237
Correspondent Contact BRADLEY J BUSHMAN
Regulation Number878.4040
Classification Product Code
FYA  
Date Received07/19/2001
Decision Date 12/03/2001
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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