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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 K093897
Device Name SMITH & NEPHEW FOOTPRINT ULTRA PK SUTURE ANCHOR
Applicant
SMITH & NEPHEW INC., ENDOSCOPY DIV.
150 MINUTEMAN RD.
ANDOVER,  MA  01810
Applicant Contact CHRISTINA FLORES
Correspondent
SMITH & NEPHEW INC., ENDOSCOPY DIV.
150 MINUTEMAN RD.
ANDOVER,  MA  01810
Correspondent Contact CHRISTINA FLORES
Regulation Number888.3040
Classification Product Code
MBI  
Date Received12/18/2009
Decision Date 03/04/2010
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
Recalls CDRH Recalls
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