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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 K000651
Device Name DETACH 18 AND DETACH 11, NEUROLOGICAL EMBOLIZATION COIL SYSTEM
Applicant
COOK, INC.
925 SOUTH CURRY PIKE
P.O. BOX 489
BLOOMINGTON,  IN  47402
Applicant Contact LISA WEBB
Correspondent
COOK, INC.
925 SOUTH CURRY PIKE
P.O. BOX 489
BLOOMINGTON,  IN  47402
Correspondent Contact LISA WEBB
Regulation Number882.5950
Classification Product Code
HCG  
Date Received02/28/2000
Decision Date 11/24/2000
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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