FDA 510(k) Application Details - K972997

Device Classification Name	Stimulator, Muscle, Powered   More FDA Info for this Device
510(K) Number	K972997
Device Name	Stimulator, Muscle, Powered
Applicant	DAN MED, INC. 494 SHERIDAN BLVD., STE. 204 DENVER, CO 80226 US Other 510(k) Applications for this Company
Contact	THOMAS SANDGAARD 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	08/12/1997
Decision Date	11/10/1997
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