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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, nondegradable, soft tissue
510(K) Number K113294
Model 72203378,7220339,72203380
Device Name SMITH & NEPHEW HEALICOIL PK SUTURE ANCHOR
Applicant
SMITH & NEPHEW, INC.
150 minuteman rd.
andover,  MA  01810
Contact elizabeth lavelle
Regulation Number888.3040
Classification Product Code
MBI  
Date Received11/08/2011
Decision Date 01/20/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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