FDA 510(k) Application Details - K982915

Device Classification Name	Varnish, Cavity   More FDA Info for this Device
510(K) Number	K982915
Device Name	Varnish, Cavity
Applicant	SCIENTIFIC PHARMACEUTICALS, INC. 3221 PRODUCER WAY POMONA, CA 91768-3916 US Other 510(k) Applications for this Company
Contact	JAN A ORLOWSKI Other 510(k) Applications for this Contact
Regulation Number	872.3260   More FDA Info for this Regulation Number
Classification Product Code	LBH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/19/1998
Decision Date	02/12/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review