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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 K152969
Device Name ENHANCE ALLOGRAFT WEDGE INSTRUMENT TRAY
Applicant
Conmed Corporation
525 French Rd.
Utica,  NY  13502
Applicant Contact DIONNE SANDERS
Correspondent
Conmed Corporation
525 French Rd.
Utica,  NY  13502
Correspondent Contact DIONNE SANDERS
Regulation Number880.6850
Classification Product Code
KCT  
Date Received10/08/2015
Decision Date 03/31/2016
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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