FDA 510(k) Application Details - K980106

Device Classification Name	Unit, Operative Dental   More FDA Info for this Device
510(K) Number	K980106
Device Name	Unit, Operative Dental
Applicant	PROMA, INC. 751 EAST KINGSHILL PL. CARSON, CA 90746-1223 US Other 510(k) Applications for this Company
Contact	FRANK A BETUSH Other 510(k) Applications for this Contact
Regulation Number	872.6640   More FDA Info for this Regulation Number
Classification Product Code	EIA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/12/1998
Decision Date	08/03/1998
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