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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 K123803
Device Name REVERSE MEDICAL MICRO VASCULAR PLUG (MVP) SYSTEM
Applicant
REVERSE MEDICAL CORPORATION
13700 ALTON PARKWAY SUITE 167
IRVINE,  CA  92618
Applicant Contact JEFFREY VALKO
Correspondent
REVERSE MEDICAL CORPORATION
13700 ALTON PARKWAY SUITE 167
IRVINE,  CA  92618
Correspondent Contact JEFFREY VALKO
Regulation Number870.3300
Classification Product Code
KRD  
Date Received12/10/2012
Decision Date 07/02/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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