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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
FOIA Releasable 510(k) K113294
Device Name SMITH & NEPHEW HEALICOIL PK SUTURE ANCHOR
Applicant
SMITH & NEPHEW, INC.
150 MINUTEMAN RD.
ANDOVER,  MA  01810
Applicant Contact ELIZABETH LAVELLE
Correspondent
SMITH & NEPHEW, INC.
150 MINUTEMAN RD.
ANDOVER,  MA  01810
Correspondent Contact ELIZABETH LAVELLE
Regulation Number888.3040
Classification Product Code
MBI  
Date Received11/08/2011
Decision Date 01/20/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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