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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
Applicant
SMITH & NEPHEW INC., ENDOSCOPY DIVISION
150 Minuteman Rd
ANDOVER,  MA  01810
Applicant Contact JANICE HASELTON
Correspondent
SMITH & NEPHEW INC., ENDOSCOPY DIVISION
150 Minuteman Rd
ANDOVER,  MA  01810
Correspondent 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
Predetermined Change
Control Plan Authorized		 No
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