510(k) K050735

MC6A by Macan Engineering Co. — Product Code EKZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 2005
Date Received
March 21, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Electrosurgical, And Accessories, Dental
Device Class
Class II
Regulation Number
872.4920
Review Panel
DE
Submission Type