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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 K971139
Device Name BONE ANCHOR SYSTEM FOR SOFT TISSUE SUPPORT
Applicant
BOSTON SCIENTIFIC CORP.
ONE BOSTON SCIENTIFIC PL.
NATICK,  MA  01760 -1537
Applicant Contact CAROL J HOLLOWAY
Correspondent
BOSTON SCIENTIFIC CORP.
ONE BOSTON SCIENTIFIC PL.
NATICK,  MA  01760 -1537
Correspondent Contact CAROL J HOLLOWAY
Regulation Number888.3040
Classification Product Code
MBI  
Subsequent Product Code
HWC  
Date Received03/28/1997
Decision Date 06/25/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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