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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 K102122
Device Name SMITH & NEPHEW MILTI-PURPOSE STERILIZATION TRAY MODEL 72202428
Applicant
Smith & Nephew, Inc.
130 Forbes Blvd.
Mansfield,  MA  02048
Applicant Contact CHRISTINA FLORES
Correspondent
Smith & Nephew, Inc.
130 Forbes Blvd.
Mansfield,  MA  02048
Correspondent Contact CHRISTINA FLORES
Regulation Number880.6850
Classification Product Code
KCT  
Date Received07/29/2010
Decision Date 11/22/2010
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
Predetermined Change
Control Plan Authorized		 No
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