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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name device, vascular, for promoting embolization
510(k) Number K112103
Model M001363XXX
Device Name INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM
Original Applicant
BOSTON SCIENTIFIC CORP.
one scimed place
maple grove,  MN  55311
Original Contact harlan jones
Regulation Number870.3300
Classification Product Code
KRD  
Date Received07/22/2011
Decision Date 08/12/2011
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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