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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 K172390
Device Name Optima Coil System
Applicant
Blockade Medical, LLC (D.B.A. Balt Usa)
18 Technology Dr. Suite 169
Irvine,  CA  92618
Applicant Contact Rebecca K. Pine
Correspondent
Blockade Medical, LLC (D.B.A. Balt Usa)
18 Technology Dr. Suite 169
Irvine,  CA  92618
Correspondent Contact Rebecca K. Pine
Regulation Number882.5950
Classification Product Code
HCG  
Date Received08/08/2017
Decision Date 02/18/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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