FDA 510(k) Application Details - K052622

Device Classification Name Unit, Electrosurgical, And Accessories, Dental

  More FDA Info for this Device
510(K) Number K052622
Device Name Unit, Electrosurgical, And Accessories, Dental
Applicant MACAN ENGINEERING CO.
1564 NORTH DAMEN AVE.
CHICAGO, IL 60622 US
Other 510(k) Applications for this Company
Contact MICKEY ALBERGO
Other 510(k) Applications for this Contact
Regulation Number 872.4920

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

  More FDA Info for this Product Code
Date Received 09/23/2005
Decision Date 12/09/2005
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