FDA 510(k) Application Details - K992893

Device Classification Name	Unit, Operative Dental   More FDA Info for this Device
510(K) Number	K992893
Device Name	Unit, Operative Dental
Applicant	MRLB INTL., INC. 2450 COLLEGE WAY FERGUS FALLS, MN 56537 US Other 510(k) Applications for this Company
Contact	B.J. HAMMARBACK 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	08/27/1999
Decision Date	09/08/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review