FDA 510(k) Application Details - K981182

Device Classification Name	Bone Grafting Material, Synthetic   More FDA Info for this Device
510(K) Number	K981182
Device Name	Bone Grafting Material, Synthetic
Applicant	CERAMED DENTAL, LLC. 12860 WEST CEDAR DR., SUITE 110 LAKEWOOD, CO 80228 US Other 510(k) Applications for this Company
Contact	MARK BOWERMAN Other 510(k) Applications for this Contact
Regulation Number	872.3930   More FDA Info for this Regulation Number
Classification Product Code	LYC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/01/1998
Decision Date	07/02/1998
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