FDA 510(k) Application Details - K970116

Device Classification Name	Device, Dental Sonography, For Monitoring Jaw Sounds   More FDA Info for this Device
510(K) Number	K970116
Device Name	Device, Dental Sonography, For Monitoring Jaw Sounds
Applicant	MYO-TRONICS, INC. 15425 - 33RD AVENUE SOUTH TUKWILA, WA 98188 US Other 510(k) Applications for this Company
Contact	FRAY ADIB Other 510(k) Applications for this Contact
Regulation Number	872.2050   More FDA Info for this Regulation Number
Classification Product Code	NFQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/13/1997
Decision Date	04/02/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review