FDA 510(k) Application Details - K092435

Device Classification Name	Massager, Powered Inflatable Tube   More FDA Info for this Device
510(K) Number	K092435
Device Name	Massager, Powered Inflatable Tube
Applicant	THE AMERICAN EXPORT GROUP & INTERNATIONAL SERVICES 1131 ANTHEM VIEW LANE KNOXVILLE, TN 37922 US Other 510(k) Applications for this Company
Contact	ROBERT WAGNER 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	08/07/2009
Decision Date	03/09/2010
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