FDA 510(k) Application Details - K970626

Device Classification Name	Unit, Operative Dental   More FDA Info for this Device
510(K) Number	K970626
Device Name	Unit, Operative Dental
Applicant	I.C.S. 10054 MESA RIDGE COURT SUITE 104 SAN DIEGO, CA 92121 US Other 510(k) Applications for this Company
Contact	ALAN CREAMER 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	02/19/1997
Decision Date	04/04/1997
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