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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name powered laser surgical instrument
510(k) Number K110685
Device Name FLEXIVA TRACTIP
Applicant
BOSTON SCIENTIFIC CORP.
100 BOSTON SCIENTIFIC WAY
M21
MARLBOROUGH,  MA  01752
Applicant Contact LAUREN ANDERSON
Correspondent
BOSTON SCIENTIFIC CORP.
100 BOSTON SCIENTIFIC WAY
M21
MARLBOROUGH,  MA  01752
Correspondent Contact LAUREN ANDERSON
Regulation Number878.4810
Classification Product Code
GEX  
Date Received03/11/2011
Decision Date 03/29/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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