FDA 510(k) Application Details - K994057

Device Classification Name	Massager, Powered Inflatable Tube   More FDA Info for this Device
510(K) Number	K994057
Device Name	Massager, Powered Inflatable Tube
Applicant	MEDICAL COMPRESSION SYSTEMS (D.B.N.) LTD. 117 AHUZAH ST. RA'ANANNA 43373 43373 IL Other 510(k) Applications for this Company
Contact	SHOSHANA FRIEDMAN Other 510(k) Applications for this Contact
Regulation Number	890.5650   More FDA Info for this Regulation Number
Classification Product Code	IRP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/30/1999
Decision Date	03/03/2000
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