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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 K925813
Device Name DIAGNOSTIC INTRAVASCULAR CATHETER
Applicant
TARGET THERAPEUTICS
47201 LAKEVIEW BLVD.
P.O. BOX 5120
FREEMONT,  CA  94538
Applicant Contact LARAINE PANGELINA
Correspondent
TARGET THERAPEUTICS
47201 LAKEVIEW BLVD.
P.O. BOX 5120
FREEMONT,  CA  94538
Correspondent Contact LARAINE PANGELINA
Regulation Number870.1200
Classification Product Code
DQO  
Date Received11/17/1992
Decision Date 03/23/1994
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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