FDA 510(k) Application Details - K162218

Device Classification Name	Refrigerant, Topical (Vapocoolant)   More FDA Info for this Device
510(K) Number	K162218
Device Name	Refrigerant, Topical (Vapocoolant)
Applicant	NUANCE MEDICAL, LLC 5931 Sea Lion Place, Suite 113 Carlsbad, CA 92008 US Other 510(k) Applications for this Company
Contact	MARC LIEBERMAN 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	08/08/2016
Decision Date	11/22/2016
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