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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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