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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name trocar
510(K) Number K122832
Model 1009455-XXX
Device Name MOBICATH TRANSSEPTAL NEEDLE
Applicant
GREATBATCH MEDICAL
2300 berkshire lane north
minneapolis,  MN  55441
Contact denise thompson
Regulation Number870.1390
Classification Product Code
DRC  
Date Received09/17/2012
Decision Date 12/19/2012
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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