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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 K073163
Device Name LIMITED ARTIFACT SKULL PIN, MODEL 0107
Applicant
DINKLER SURGICAL DEVICES, INC.
174 LOOKOUT DRIVE
DAYTON,  OH  45419
Applicant Contact CHARLES E DINKLER II
Correspondent
DINKLER SURGICAL DEVICES, INC.
174 LOOKOUT DRIVE
DAYTON,  OH  45419
Correspondent Contact CHARLES E DINKLER II
Regulation Number882.4460
Classification Product Code
HBL  
Date Received11/09/2007
Decision Date 02/28/2008
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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