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510(k) K193596

Wingman 14, Wingman 14C, Wingman 18, Wingman 35 by Reflow Medical — Product Code DQY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 20, 2020
Date Received
December 23, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Percutaneous
Device Class
Class II
Regulation Number
870.1250
Review Panel
CV
Submission Type

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