FDA 510(k) Application Details - K970930

Device Classification Name	Retainer, Screw Expansion, Orthodontic   More FDA Info for this Device
510(K) Number	K970930
Device Name	Retainer, Screw Expansion, Orthodontic
Applicant	CLEFT PALATE APPLIANCES, INC. 218 COMMISIONERS RD., WEST LONDON N6J 1Y1 CA Other 510(k) Applications for this Company
Contact	ELIZABETH ANN LATHAM Other 510(k) Applications for this Contact
Regulation Number	872.5410   More FDA Info for this Regulation Number
Classification Product Code	DYJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/13/1997
Decision Date	04/23/1997
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