FDA 510(k) Application Details - K090457

Device Classification Name	Oral Lubricant   More FDA Info for this Device
510(K) Number	K090457
Device Name	Oral Lubricant
Applicant	PULPDENT CORPORATION 80 OAKLAND ST. WATERTOWN, MA 02472 US Other 510(k) Applications for this Company
Contact	KENNETH J BERK Other 510(k) Applications for this Contact
Regulation Number	880.6375   More FDA Info for this Regulation Number
Classification Product Code	ONK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/23/2009
Decision Date	05/21/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review