FDA 510(k) Application Details - K133981

Device Classification Name	Pad, Heating, Powered   More FDA Info for this Device
510(K) Number	K133981
Device Name	Pad, Heating, Powered
Applicant	AVACEN INC. 7920 SILVERTON AVENUE SUITE L SAN DIEGO, CA 92126 US Other 510(k) Applications for this Company
Contact	THOMAS G MUEHLABUER Other 510(k) Applications for this Contact
Regulation Number	890.5740   More FDA Info for this Regulation Number
Classification Product Code	IRT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/26/2013
Decision Date	08/15/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review