FDA 510(k) Application Details - K974395

Device Classification Name	Massager, Powered Inflatable Tube   More FDA Info for this Device
510(K) Number	K974395
Device Name	Massager, Powered Inflatable Tube
Applicant	GRAD-LINE CORP. 762 SOUTH FEDERAL HIGHWAY DEERFIELD, FL 33441 US Other 510(k) Applications for this Company
Contact	WALTER L WASSERMAN 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	11/21/1997
Decision Date	10/22/1998
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