FDA 510(k) Application Details - K984641

Device Classification Name	Unit, Operative Dental   More FDA Info for this Device
510(K) Number	K984641
Device Name	Unit, Operative Dental
Applicant	SCHOELLY FIBEROPTIC, GMBH 45 PONTIAC RD. NEWTON, MA 02248 US Other 510(k) Applications for this Company
Contact	JOSEPH RESS 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	12/31/1998
Decision Date	03/29/1999
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