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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Holder, Head, Neurosurgical (Skull Clamp)
510(k) Number K122225
Device Name STERILE RADIOLUCENT SKULL PINS
Applicant
BRAINLAB AG
KAPELLENSTRASSE 12
FELDKIRCHEN,  DE 85622
Applicant Contact ALEXANDER SCHWIERSCH
Correspondent
BRAINLAB AG
KAPELLENSTRASSE 12
FELDKIRCHEN,  DE 85622
Correspondent Contact ALEXANDER SCHWIERSCH
Regulation Number882.4460
Classification Product Code
HBL  
Date Received07/25/2012
Decision Date 04/26/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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