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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 K073551
Device Name SMITH & NEPHEW INSTRUMENT TRAYS
Applicant
SMITH & NEPHEW INC., ENDOSCOPY DIV.
130 FORBES BLVD.
MANSFIELD,  MA  02048
Applicant Contact JULIE ACKER
Correspondent
SMITH & NEPHEW INC., ENDOSCOPY DIV.
130 FORBES BLVD.
MANSFIELD,  MA  02048
Correspondent Contact JULIE ACKER
Regulation Number880.6850
Classification Product Code
KCT  
Date Received12/18/2007
Decision Date 05/21/2008
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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