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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 K121904
Device Name GYNECOLOGY STERILIZATION TRAY
Original Applicant
SMITH & NEPHEW INC., ENDOSCOPY DIVISION
150 minuteman rd
andover,  MA  01810
Original Contact janice haselton
Regulation Number880.6850
Classification Product Code
KCT  
Date Received06/29/2012
Decision Date 03/11/2013
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
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