FDA 510(k) Application Details - K980346

Device Classification Name	Stimulator, Muscle, Powered   More FDA Info for this Device
510(K) Number	K980346
Device Name	Stimulator, Muscle, Powered
Applicant	UNIVERSAL TECHNOLOGY SYSTEMS, INC. 5150-4 TIMUQUANA RD. JACKSONVILLE, FL 32210 US Other 510(k) Applications for this Company
Contact	GARY HEINEY Other 510(k) Applications for this Contact
Regulation Number	890.5850   More FDA Info for this Regulation Number
Classification Product Code	IPF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/28/1998
Decision Date	04/28/1998
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