FDA 510(k) Application Details - K990381

Device Classification Name	Cement, Dental   More FDA Info for this Device
510(K) Number	K990381
Device Name	Cement, Dental
Applicant	PARKELL, INC. 155 SCHMITT BLVD. P.O. BOX 376 FARMINGDALE, NY 11735 US Other 510(k) Applications for this Company
Contact	NELSON J GENDUSA Other 510(k) Applications for this Contact
Regulation Number	872.3275   More FDA Info for this Regulation Number
Classification Product Code	EMA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/08/1999
Decision Date	05/17/1999
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