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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 K102544
Device Name SMITH & NEPHEW HIP ARTHROSCOPY REPAIR INSTRUMENT TRAY
Applicant
Smith & Nephew Inc., Endoscopy Div.
130 Forbes Blvd.
Mansfield,  MA  02048
Applicant Contact KATHLEEN SOLOMON
Correspondent
Smith & Nephew Inc., Endoscopy Div.
130 Forbes Blvd.
Mansfield,  MA  02048
Correspondent Contact KATHLEEN SOLOMON
Regulation Number880.6850
Classification Product Code
KCT  
Date Received09/03/2010
Decision Date 01/05/2011
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
Recalls CDRH Recalls
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