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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 K063494
Device Name DORO RADIOLUCENT HEADREST SYSTEM ( ALSO MRI-COMPATIBLE) AND COMPONENTS
Applicant
PRO-MED INSTRUMENTS GMBH
5450 LEE ST, STE 1
LEHIGH ACRES,  FL  33971
Applicant Contact EDGAR SCHUELE
Correspondent
PRO-MED INSTRUMENTS GMBH
5450 LEE ST, STE 1
LEHIGH ACRES,  FL  33971
Correspondent Contact EDGAR SCHUELE
Regulation Number882.4460
Classification Product Code
HBL  
Date Received11/20/2006
Decision Date 05/21/2007
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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