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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
510(k) Number K130720
Device Name SYNTHES REUSABLE STERILIZATION CONTAINER SYSTEM
Applicant
Synthes (USA) Products, LLC
1302 Wrights Lane E.
West Chester,  PA  19380
Applicant Contact THOMAS SHEA
Correspondent
Synthes (USA) Products, LLC
1302 Wrights Lane E.
West Chester,  PA  19380
Correspondent Contact THOMAS SHEA
Regulation Number880.6850
Classification Product Code
KCT  
Date Received03/18/2013
Decision Date 08/14/2014
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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