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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 K092551
Device Name SMITH & NEPHEW INSTRUMENT TRAYS
Applicant
SMITH & NEPHEW INC., ENDOSCOPY DIV.
150 MINUTEMAN RD.
ANDOVER,  MA  01810
Applicant Contact CHRISTINA FLORES
Correspondent
SMITH & NEPHEW INC., ENDOSCOPY DIV.
150 MINUTEMAN RD.
ANDOVER,  MA  01810
Correspondent Contact CHRISTINA FLORES
Regulation Number880.6850
Classification Product Code
KCT  
Date Received08/20/2009
Decision Date 09/14/2010
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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