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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
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