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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 K092414
Device Name CONMED DETACHATIP INSTRUMENT TRAY, 33CM AND 43CM
Applicant
Conmed Corporation
525 French Rd.
Utica,  NY  13502
Applicant Contact SANDY COVELESKI
Correspondent
Conmed Corporation
525 French Rd.
Utica,  NY  13502
Correspondent Contact SANDY COVELESKI
Regulation Number880.6850
Classification Product Code
KCT  
Date Received08/07/2009
Decision Date 03/10/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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