FDA 510(k) Application Details - K201248

Device Classification Name	Refrigerant, Topical (Vapocoolant)   More FDA Info for this Device
510(K) Number	K201248
Device Name	Refrigerant, Topical (Vapocoolant)
Applicant	Vapocoolshot, Inc. 1155 Main Street, suite 105 Jupiter, FL 33458 US Other 510(k) Applications for this Company
Contact	Jacob Leibovici Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	MLY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/11/2020
Decision Date	08/12/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review