FDA 510(k) Application Details - K964619

Device Classification Name	Unit, Operative Dental   More FDA Info for this Device
510(K) Number	K964619
Device Name	Unit, Operative Dental
Applicant	SDS DENTAL, INC. 5101 N.W. 21ST AVE. N.W. SUITE 141 FORT LAUDERDALE, FL 33309 US Other 510(k) Applications for this Company
Contact	CESAR CORAL Other 510(k) Applications for this Contact
Regulation Number	872.6640   More FDA Info for this Regulation Number
Classification Product Code	EIA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/18/1996
Decision Date	01/22/1997
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