FDA 510(k) Application Details - K032099

Device Classification Name Activator, Ultraviolet, For Polymerization

  More FDA Info for this Device
510(K) Number K032099
Device Name Activator, Ultraviolet, For Polymerization
Applicant (EMS SA) ELECTRO MEDICAL SYSTEMS
49 PLAIN ST.
NORTH ATTLEBORO, MA 02760 US
Other 510(k) Applications for this Company
Contact CYNTHIA J M. NOLTE
Other 510(k) Applications for this Contact
Regulation Number 872.6070

  More FDA Info for this Regulation Number
Classification Product Code EBZ
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 07/08/2003
Decision Date 10/27/2003
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



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact