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510(k) K202782

num Vapocoolant by 623 Medical, LLC — Product Code MLY

K202782 is an FDA 510(k) premarket notification submitted by 623 Medical, LLC for the device "num Vapocoolant". The FDA issued a decision of Substantially Equivalent on December 21, 2020. The device falls under product code MLY (Vapocoolant Device), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 2020
Date Received
September 22, 2020
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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FDA data resources