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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 K911560
Device Name ZEPHYR INFUSION CATHETER
Applicant
TARGET THERAPEUTICS
130 rio robles
p.o. box 610458
san jose,  CA  95134
Contact wendy j zenzen
Regulation Number870.1200
Classification Product Code
DQO  
Date Received04/08/1991
Decision Date 07/05/1991
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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