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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Arthroscope
510(k) Number K072675
Device Name SMITH & NEPHEW ARTHROSCOPE
Applicant
SMITH & NEPHEW, INC.
150 Minuteman Road
Andover,  MA  01810
Applicant Contact JANICE HASELTON
Correspondent
SMITH & NEPHEW, INC.
150 Minuteman Road
Andover,  MA  01810
Correspondent Contact JANICE HASELTON
Regulation Number888.1100
Classification Product Code
HRX  
Date Received09/21/2007
Decision Date 10/15/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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