FDA 510(k) Application Details - K973289

Device Classification Name	Agent, Polishing, Abrasive, Oral Cavity   More FDA Info for this Device
510(K) Number	K973289
Device Name	Agent, Polishing, Abrasive, Oral Cavity
Applicant	PACIFIC RIM DENTAL, INC. 173CD SHADY LN. P.O. BOX 2147 STATELINE, NV 89449 US Other 510(k) Applications for this Company
Contact	KATHY L EPPEN 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	09/02/1997
Decision Date	02/09/1999
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