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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 K911605
Device Name TRACKER UNIBODY, UNIBODY W/SIDE & 25 SIDE HOLES
Applicant
TARGET THERAPEUTICS
130 RIO ROBLES
P.O. BOX 610458
SAN JOSE,  CA  95134
Applicant Contact ALEXIS BALL
Correspondent
TARGET THERAPEUTICS
130 RIO ROBLES
P.O. BOX 610458
SAN JOSE,  CA  95134
Correspondent Contact ALEXIS BALL
Regulation Number870.1200
Classification Product Code
DQO  
Date Received04/10/1991
Decision Date 07/09/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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