FDA 510(k) Application Details - K190161

Device Classification Name	Refrigerant, Topical (Vapocoolant)   More FDA Info for this Device
510(K) Number	K190161
Device Name	Refrigerant, Topical (Vapocoolant)
Applicant	Gebauer Company 4444 East 153rd Street Cleveland, OH 44128 US Other 510(k) Applications for this Company
Contact	Brittney Cooper 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	01/30/2019
Decision Date	05/07/2019
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