FDA 510(k) Application Details - K000655

Device Classification Name	Massager, Powered Inflatable Tube   More FDA Info for this Device
510(K) Number	K000655
Device Name	Massager, Powered Inflatable Tube
Applicant	AHAVA STEIN P.O.B. 454 GINOT SHOMRON, 44853 IL Other 510(k) Applications for this Company
Contact	AHAVA STEIN 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	02/28/2000
Decision Date	03/26/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review