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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, intravascular, diagnostic
510(k) Number K960806
Device Name TURBO TRACKER
Original Applicant
TARGET THERAPEUTICS
47201 lakeview blvd.
p.o. box 5120
freemont,  CA  94538
Original Contact abhi acharyn
Regulation Number870.1200
Classification Product Code
DQO  
Date Received02/28/1996
Decision Date 05/02/1996
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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