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510(k) K153038

Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable Inflation Device, Everest 30 Survival Kit by Medtronic, Inc. — Product Code MAV

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
April 13, 2016
Date Received
October 19, 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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Other clearances for product code MAV

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  • K143522 — Presto Inflation Device (January 12, 2015)
  • K133795 — SUMMED INFLATION DEVICE KIT (December 12, 2014)
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