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510(k) K193349

Vapocoolshot Mist by Vapocoolshot, Inc. — Product Code MLY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 2020
Date Received
December 3, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Vapocoolant Device
Device Class
Class U
Regulation Number
Review Panel
PM
Submission Type

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