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510(k) K153672

basixTOUCH40 Inflation Syringe by Merit Medical Systems, Inc. — Product Code MAV

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
January 20, 2016
Date Received
December 21, 2015
Clearance Type
Special
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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  • K143522 — Presto Inflation Device (January 12, 2015)
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