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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 (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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