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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wrap, Sterilization
510(k) Number K162162
Device Name Barrier Supreme Sterilization Wrapper
Applicant
Standard Textile Co., Inc.
One Knollcrest Drive
Cincinnati,  OH  45237
Applicant Contact Bradley J. Bushman
Correspondent
Hogan Lovells US LLP
555 Thirteenth Street, NW
Washington,  DC  20004 -1109
Correspondent Contact Jonathan Kahan
Regulation Number880.6850
Classification Product Code
FRG  
Date Received08/02/2016
Decision Date 11/04/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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