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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name drills, burrs, trephines & accessories (compound, powered)
510(k) Number K121253
Model PER 6-9SP; PER 7-11-SP; PER 11-14-SP; PER 6-9-S; PER 7-11-S; PER 11-14-S
Device Name MERIDIAN CRANIAL PERFORATOR
Original Applicant
ADEOR MEDICAL TECHNOLOGIES GMBH
kirchplatz 1
pullach,  GM 82049
Original Contact fabio von zeppelin
Regulation Number882.4305
Classification Product Code
HBF  
Date Received04/27/2012
Decision Date 07/17/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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