FDA 510(k) Application Details - K983847

Device Classification Name	Unit, Operative Dental   More FDA Info for this Device
510(K) Number	K983847
Device Name	Unit, Operative Dental
Applicant	GERMIPHENE CORP. 1379 COLBORNE ST., EAST BRANTFORD, ONT N3T 5V7 CA Other 510(k) Applications for this Company
Contact	LESLIE DRAKE 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	10/30/1998
Decision Date	12/01/1998
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