FDA 510(k) Application Details - K031998

Device Classification Name Stimulator, Muscle, Powered, Dental

  More FDA Info for this Device
510(K) Number K031998
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 06/27/2003
Decision Date 07/24/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact