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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 K961923
Device Name BERENSTEIN COIL
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 Received05/17/1996
Decision Date 08/15/1996
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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