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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 K083803
Device Name FIXIT HEADREST CLAMP SYSTEM
Applicant
Medicon EG
Gaensaecker 15
Tuttlingen,  DE D-78532
Applicant Contact JOACHIM SCHMID
Correspondent
Medicon EG
Gaensaecker 15
Tuttlingen,  DE D-78532
Correspondent Contact JOACHIM SCHMID
Regulation Number882.4460
Classification Product Code
HBL  
Date Received12/22/2008
Decision Date 03/10/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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