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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K002274
Device Name SMITH & NEPHEW SUTURE HAPLA INTERFERENCE SCREW
Applicant
Smith & Nephew, Inc.
160 Dascomb Rd.
Andover,  MA  01810
Applicant Contact TEDD GOSIAN
Correspondent
Smith & Nephew, Inc.
160 Dascomb Rd.
Andover,  MA  01810
Correspondent Contact TEDD GOSIAN
Regulation Number888.3040
Classification Product Code
HWC  
Date Received07/26/2000
Decision Date 03/07/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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