FDA 510(k) Application Details - K991946

Device Classification Name	Unit, Operative Dental   More FDA Info for this Device
510(K) Number	K991946
Device Name	Unit, Operative Dental
Applicant	STERILEX CORP. 7-I GWYNNS HILL COURT OWINS MILLS, MD 21117 US Other 510(k) Applications for this Company
Contact	SHIRA KRAMER 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	06/09/1999
Decision Date	09/03/1999
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