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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K122684
Device Name REVERSE MEDICAL MICROCATHETER
Applicant
Reverse Medical Corporation
13700 Alton Pkwy., Suite 167
Irvine,  CA  92618
Applicant Contact JEFFREY VALKO
Correspondent
Reverse Medical Corporation
13700 Alton Pkwy., Suite 167
Irvine,  CA  92618
Correspondent Contact JEFFREY VALKO
Regulation Number870.1250
Classification Product Code
DQY  
Subsequent Product Code
KRA  
Date Received08/31/2012
Decision Date 12/07/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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