FDA 510(k) Application Details - K022097

Device Classification Name	Tester, Pulp   More FDA Info for this Device
510(K) Number	K022097
Device Name	Tester, Pulp
Applicant	PARKELL, INC. 155 SCHMITT BLVD. P.O. BOX 376 FARMINGDALE, NY 11735 US Other 510(k) Applications for this Company
Contact	DANIEL R SCHECHTER Other 510(k) Applications for this Contact
Regulation Number	872.1720   More FDA Info for this Regulation Number
Classification Product Code	EAT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/27/2002
Decision Date	09/06/2002
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