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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Vascular, For Promoting Embolization
510(k) Number K200083
Device Name EMBA Hourglass Peripheral Embolization Device (PED)
Applicant
Embolic Acceleration, LLC
3451 Commerce Pkwy.
Miami,  FL  33025
Applicant Contact Veronica McDougall
Correspondent
Embolic Acceleration, LLC
3451 Commerce Pkwy.
Miami,  FL  33025
Correspondent Contact Veronica McDougall
Regulation Number870.3300
Classification Product Code
KRD  
Date Received01/15/2020
Decision Date 02/14/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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