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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, intravascular, diagnostic
510(K) Number K011664
Device Name IMAGER II ANGIOGRAPHIC CATHETER
Applicant
BOSTON SCIENTIFIC/MEDI-TECH
one boston scientific place
natick,  MA  01760 1537
Contact jodi l greenizen
Regulation Number870.1200
Classification Product Code
DQO  
Date Received05/30/2001
Decision Date 09/07/2001
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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