FDA 510(k) Application Details - K010665

Device Classification Name	Stimulator, Muscle, Powered   More FDA Info for this Device
510(K) Number	K010665
Device Name	Stimulator, Muscle, Powered
Applicant	TRANSAMERICA MEDICAL SYSTEMS 350 RACE ST. HOLYOKE, MA 01040 US Other 510(k) Applications for this Company
Contact	JOHN F DUNN 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	03/06/2001
Decision Date	04/27/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review