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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 K133116
Device Name VIDEO EXTENDED LENGTH TRAY (PLASTIC - RADEL), VIDEO TRAY SINGLE LEVEL (PLASTIC - RADEL), VIDEO ARTHROSCOPE TRAY (PLASTIC
Applicant
Conmed Corporation
134 Flanders Rd.
Westborough,  MA  01581
Applicant Contact NANCY GERTLAR
Correspondent
Conmed Corporation
134 Flanders Rd.
Westborough,  MA  01581
Correspondent Contact NANCY GERTLAR
Regulation Number880.6850
Classification Product Code
KCT  
Date Received09/30/2013
Decision Date 03/28/2014
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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