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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 K913312
Device Name HELIX SHAPED COILS WITH DACRON FIBERS, MODIFIED
Applicant
TARGET THERAPEUTICS
130 RIO ROBLES
P.O. BOX 610458
SAN JOSE,  CA  95134
Applicant Contact LLOYD H GRIESE
Correspondent
TARGET THERAPEUTICS
130 RIO ROBLES
P.O. BOX 610458
SAN JOSE,  CA  95134
Correspondent Contact LLOYD H GRIESE
Regulation Number882.5950
Classification Product Code
HCG  
Date Received07/25/1991
Decision Date 11/08/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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