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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name device, vascular, for promoting embolization
510(k) Number K955293
Device Name FIBERED PLATINUM COIL, .035 TYPE
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 Number870.3300
Classification Product Code
KRD  
Date Received11/16/1995
Decision Date 02/06/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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