FDA 510(k) Application Details - K961893

Device Classification Name	Varnish, Cavity   More FDA Info for this Device
510(K) Number	K961893
Device Name	Varnish, Cavity
Applicant	PHARMASCIENCE, INC. 8235 ROANOKE CT. SEVERN, MD 21144 US Other 510(k) Applications for this Company
Contact	LOUIS HLAVINKA 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	05/16/1996
Decision Date	08/14/1996
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