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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 K060519
Device Name INTRODUCER ASSEMBLY WITH ROTATOR LOCK
Applicant
TELEFLEX MEDICAL
2345 WAUKEGAN ROAD
SUITE 140
BANNOCKBURN,  IL  60015
Applicant Contact LORI HAYS
Correspondent
TELEFLEX MEDICAL
2345 WAUKEGAN ROAD
SUITE 140
BANNOCKBURN,  IL  60015
Correspondent Contact LORI HAYS
Regulation Number870.1340
Classification Product Code
DYB  
Date Received02/27/2006
Decision Date 05/05/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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