FDA 510(k) Application Details - K984564

Device Classification Name	Refrigerant, Topical (Vapocoolant)   More FDA Info for this Device
510(K) Number	K984564
Device Name	Refrigerant, Topical (Vapocoolant)
Applicant	DUKAL CORP. 3234 ELLA LN. NEW PORT RICHE, FL 34655 US Other 510(k) Applications for this Company
Contact	ED RASOM 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	12/23/1998
Decision Date	12/02/1999
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