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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 K132482
Device Name BARRICADE EMBOLIZATION COIL SYSTEM
Applicant
BLOCKADE MEDICAL
18 Technology Dr Ste 169
Irvine,  CA  92618
Applicant Contact Rebecca K Pine
Correspondent
BLOCKADE MEDICAL
18 Technology Dr Ste 169
Irvine,  CA  92618
Correspondent Contact Rebecca K Pine
Regulation Number882.5950
Classification Product Code
HCG  
Date Received08/08/2013
Decision Date 10/10/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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