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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name introducer, catheter
510(k) Number K093232
Device Name OPTISEAL ENPATH VALVED PTFE PEELABLE INTRODUCER
Original Applicant
GREATBATCH MEDICAL
2300 berkshire lane north
minneapolis,  MN  55441
Original Contact shannon springer
Regulation Number870.1340
Classification Product Code
DYB  
Date Received10/14/2009
Decision Date 03/15/2010
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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