FDA 510(k) Application Details - K962370

Device Classification Name	Agent, Polishing, Abrasive, Oral Cavity   More FDA Info for this Device
510(K) Number	K962370
Device Name	Agent, Polishing, Abrasive, Oral Cavity
Applicant	CHALLENGE PRODUCTS, INC. 333 WEST WACKER DRIVE, SUITE 2600 CHICAGO, IL 60606 US Other 510(k) Applications for this Company
Contact	RICHARD O WOOD 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	06/19/1996
Decision Date	03/31/1997
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