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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 K151880
Device Name Wingman Crossing Catheter
Applicant
Reflow Medical
1003 Calle Sombra
San Clemente,  CA  92673
Applicant Contact REBECCA K PINE
Correspondent
Reflow Medical
1003 Calle Sombra
San Clemente,  CA  92673
Correspondent Contact REBECCA K PINE
Regulation Number870.1250
Classification Product Code
DQY  
Date Received07/09/2015
Decision Date 08/07/2015
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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