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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, percutaneous
510(k) Number K121077
Model 8101-B140P
Device Name NHANCER
Original Applicant
ceinturrbaan noord 150
p.o. box 234
roden, drenthe,  NL 9301 nz
Original Contact e schulting
Regulation Number870.1250
Classification Product Code
Date Received04/09/2012
Decision Date 12/21/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No