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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 K180653
Device Name Spartan eCoil System
Spartan Micro, Inc
3167 Skyway Court
Freemont,  CA  94539
Applicant Contact Mark Dias
Ambriel Associates, Inc.
411 Walnut St. Unit 9236
Green Cove Springs,  FL  32043
Correspondent Contact Vikki M. O'Connor
Regulation Number882.5950
Classification Product Code
Subsequent Product Code
Date Received03/13/2018
Decision Date 12/04/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No