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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 K060902
Device Name STARCLOSE INTRODUCER SET MODEL- 1002
Original Applicant
ABBOTT VASCULAR INC.
400 saginaw drive
redwood city,  CA  94063
Original Contact kim smith -servance
Regulation Number870.1340
Classification Product Code
DYB  
Date Received04/03/2006
Decision Date 07/07/2006
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
Recalls CDRH Recalls
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