FDA 510(k) Application Details - K032234

Device Classification Name Handpiece, Air-Powered, Dental

  More FDA Info for this Device
510(K) Number K032234
Device Name Handpiece, Air-Powered, Dental
Applicant MK-DENT GMBH
EISENHUTWEG 15
KUMHAUSEN-PREISENBERG 84036 DE
Other 510(k) Applications for this Company
Contact MARTINA GUNDEROTH
Other 510(k) Applications for this Contact
Regulation Number 872.4200

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

  More FDA Info for this Product Code
Date Received 07/21/2003
Decision Date 10/02/2003
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