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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 K032331
Device Name DORO RADIOLUCENT HEADREST SYSTEM AND HORSESHOE HEADRESTS,AND NON-RADIOLUCENT J-ARM RETRACTOR SYSTEM (ALUMINUM ALLOY)
Applicant
PRO-MED INSTRUMENTS GMBH
1899 SAWYER LANE
ALVA,  FL  33920
Applicant Contact JIM BAZZINOTTI
Correspondent
PRO-MED INSTRUMENTS GMBH
1899 SAWYER LANE
ALVA,  FL  33920
Correspondent Contact JIM BAZZINOTTI
Regulation Number882.4460
Classification Product Code
HBL  
Date Received07/29/2003
Decision Date 11/20/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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