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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 K090695
Device Name DINKLER SURGICAL SKULL CLAMP, MODEL 0308
Applicant
Dinkler Surgical Devices, Inc.
174 Lookout Dr.
Dayton,  OH  45419
Applicant Contact CHARLES E DINKLER III
Correspondent
Dinkler Surgical Devices, Inc.
174 Lookout Dr.
Dayton,  OH  45419
Correspondent Contact CHARLES E DINKLER III
Regulation Number882.4460
Classification Product Code
HBL  
Date Received03/16/2009
Decision Date 04/23/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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