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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 K181933
Device Name DePuy Synthes Sterilization Container System
Applicant
Synthes (USA) Products LLC / DePuy Orthopaedics Inc.
1301 Goshen Parkway
West Chester,  PA  19380
Applicant Contact Thomas Shea
Correspondent
Synthes (USA) Products LLC / DePuy Orthopaedics Inc.
1301 Goshen Parkway
West Chester,  PA  19380
Correspondent Contact Thomas Shea
Regulation Number880.6850
Classification Product Code
KCT  
Date Received07/19/2018
Decision Date 05/09/2019
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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