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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
Applicant
Greatbatch Medical
2300 BERKSHIRE LANE NORTH
MINNEAPOLIS,  MN  55441
Applicant Contact SHANNON SPRINGER
Correspondent
Greatbatch Medical
2300 BERKSHIRE LANE NORTH
MINNEAPOLIS,  MN  55441
Correspondent Contact SHANNON SPRINGER
Regulation Number870.1340
Classification Product Code
DYB  
Date Received10/14/2009
Decision Date 03/15/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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