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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fastener, Fixation, Biodegradable, Soft Tissue
510(k) Number K032197
Device Name TWIN FIX AB 6.5 MM SUTURE ANCHOR, MODELS 720209, 7210210, 7210211, 7210212
Applicant
Smith & Nephew, Inc.
130 Forbes Blvd.
Mansfield,  MA  02048
Applicant Contact JASON BILOBRAM
Correspondent
Smith & Nephew, Inc.
130 Forbes Blvd.
Mansfield,  MA  02048
Correspondent Contact JASON BILOBRAM
Regulation Number888.3030
Classification Product Code
MAI  
Date Received07/18/2003
Decision Date 08/08/2003
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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