510(k) K121253

MERIDIAN CRANIAL PERFORATOR by Adeor Medical Technologies GmbH — Product Code HBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 17, 2012
Date Received
April 25, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drills, Burrs, Trephines & Accessories (Compound, Powered)
Device Class
Class II
Regulation Number
882.4305
Review Panel
NE
Submission Type