FDA 510(k) Application Details - K033675

Device Classification Name Airbrush

  More FDA Info for this Device
510(K) Number K033675
Device Name Airbrush
Applicant SIRONA DENTAL SYSTEMS GMBH
49 PLAIN ST.
NORTH ATTLEBORO, MA 02760-4153 US
Other 510(k) Applications for this Company
Contact MARY MCNAMARA-CULLINANE
Other 510(k) Applications for this Contact
Regulation Number 872.6080

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

  More FDA Info for this Product Code
Date Received 11/24/2003
Decision Date 01/15/2004
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