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FDA 510(k) Application Details - K121253
Device Classification Name
Drills, Burrs, Trephines & Accessories (Compound, Powered)
More FDA Info for this Device
510(K) Number
K121253
Device Name
Drills, Burrs, Trephines & Accessories (Compound, Powered)
Applicant
ADEOR MEDICAL TECHNOLOGIES GMBH
KIRCHPLATZ 1
PULLACH 82049 DE
Other 510(k) Applications for this Company
Contact
FABIO VON ZEPPELIN
Other 510(k) Applications for this Contact
Regulation Number
882.4305
More FDA Info for this Regulation Number
Classification Product Code
HBF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/25/2012
Decision Date
07/17/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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