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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 K150108
Device Name Reverse Medical Micro Vascular Plug System
Applicant
Reverse Medical Corporation
13700 Alton Pkwy., Suite 167
Irvine,  CA  92618
Applicant Contact LAURA HEATON
Correspondent
Reverse Medical Corporation
13700 Alton Pkwy., Suite 167
Irvine,  CA  92618
Correspondent Contact LAURA HEATON
Regulation Number870.3300
Classification Product Code
KRD  
Date Received01/20/2015
Decision Date 04/22/2015
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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