FDA 510(k) Application Details - K963689

Device Classification Name	Pack, Hot Or Cold, Disposable   More FDA Info for this Device
510(K) Number	K963689
Device Name	Pack, Hot Or Cold, Disposable
Applicant	FLORIDA MEDICAL INDUSTRIES, INC. 40178 U.S. 19 NORTH TARPON SPRINGS, FL 34689 US Other 510(k) Applications for this Company
Contact	PATRICK J LAMB Other 510(k) Applications for this Contact
Regulation Number	890.5710   More FDA Info for this Regulation Number
Classification Product Code	IMD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/16/1996
Decision Date	12/12/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review