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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Neurovascular Embolization
510(k) Number K963307
Device Name GDC PATIENT RETURN ELECTTRODE MODEL 45021
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 Number882.5950
Classification Product Code
HCG  
Date Received08/22/1996
Decision Date 12/17/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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