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510(k) K152387

Fluent Inflation Device by Vascular Solutions, Inc. — Product Code MAV

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
December 18, 2015
Date Received
August 24, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Balloon Inflation
Device Class
Class II
Regulation Number
870.1650
Review Panel
CV
Submission Type

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