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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 K891688
Device Name COIL AND COIL DELIVERY SYSTEM
Applicant
TARGET THERAPEUTICS
130 RIO ROBLES
P.O. BOX 610458
SAN JOSE,  CA  95134
Applicant Contact MARIE DANIELS
Correspondent
TARGET THERAPEUTICS
130 RIO ROBLES
P.O. BOX 610458
SAN JOSE,  CA  95134
Correspondent Contact MARIE DANIELS
Regulation Number882.5950
Classification Product Code
HCG  
Date Received03/22/1989
Decision Date 09/22/1989
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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