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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
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