FDA 510(k) Application Details - K973541

Device Classification Name	Sealant, Pit And Fissure, And Conditioner   More FDA Info for this Device
510(K) Number	K973541
Device Name	Sealant, Pit And Fissure, And Conditioner
Applicant	MEDENTAL INTL. 1246 CLEAR CREEK RD. EVERGREEN, CO 80434 US Other 510(k) Applications for this Company
Contact	DEBRA GILLASPY Other 510(k) Applications for this Contact
Regulation Number	872.3765   More FDA Info for this Regulation Number
Classification Product Code	EBC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/18/1997
Decision Date	11/25/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review