FDA 510(k) Application Details - K973201

Device Classification Name	Cement, Dental   More FDA Info for this Device
510(K) Number	K973201
Device Name	Cement, Dental
Applicant	S & C POLYMER GMBH OFFENAUER WEG 19 D-25335 BOKHOLT-HARNREDDER HARNREDDER DE Other 510(k) Applications for this Company
Contact	JURGEN ENGELBRECHT Other 510(k) Applications for this Contact
Regulation Number	872.3275   More FDA Info for this Regulation Number
Classification Product Code	EMA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/26/1997
Decision Date	06/05/1998
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