FDA 510(k) Application Details - K040400

Device Classification Name	Stimulator, Muscle, Powered, Dental   More FDA Info for this Device
510(K) Number	K040400
Device Name	Stimulator, Muscle, Powered, Dental
Applicant	MYOTRONICS-NOROMED, INC. 15425 53RD AVE. SOUTH TUKWILA, WA 98188 US Other 510(k) Applications for this Company
Contact	FRAY ADIB Other 510(k) Applications for this Contact
Regulation Number	890.5850   More FDA Info for this Regulation Number
Classification Product Code	NUW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/17/2004
Decision Date	07/20/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review