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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 K001808
Device Name DORO HEADREST SYSTEM
Applicant
PRO-MED INSTRUMENTS GMBH
9070 BLUFFVIEW TRACE
ROSWELL,  GA  30076
Applicant Contact ANITA THIBEAULT
Correspondent
PRO-MED INSTRUMENTS GMBH
9070 BLUFFVIEW TRACE
ROSWELL,  GA  30076
Correspondent Contact ANITA THIBEAULT
Regulation Number882.4460
Classification Product Code
HBL  
Date Received06/15/2000
Decision Date 08/04/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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