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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 K190393
Device Name Wingman 14C Crossing Catheter
Applicant
Reflow Medical, Inc.
208 Avenida Fabricante
#100
San Clemente,  CA  92672
Applicant Contact Rebecca K Pine
Correspondent
Reflow Medical, Inc.
208 Avenida Fabricante
#100
San Clemente,  CA  92672
Correspondent Contact Rebecca K Pine
Regulation Number870.1250
Classification Product Code
DQY  
Date Received02/19/2019
Decision Date 05/09/2019
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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