FDA 510(k) Application Details - K040661

Device Classification Name	Agent, Polishing, Abrasive, Oral Cavity   More FDA Info for this Device
510(K) Number	K040661
Device Name	Agent, Polishing, Abrasive, Oral Cavity
Applicant	PASCAL CO., INC. 2929 N.E. NORTHUP WAY BELLEVUE, WA 98004 US Other 510(k) Applications for this Company
Contact	VINCENT M TENTARELLI Other 510(k) Applications for this Contact
Regulation Number	872.6030   More FDA Info for this Regulation Number
Classification Product Code	EJR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/12/2004
Decision Date	06/09/2004
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