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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drills, Burrs, Trephines & Accessories (Manual)
510(k) Number K961113
Device Name CNS INTERCHANGEABLE BIT CRANIAL DRILL
Applicant
Clinical Neuro Systems, LLC
309 Commerce Dr.
Exton,  PA  19341
Applicant Contact JIM MEIKLE
Correspondent
Clinical Neuro Systems, LLC
309 Commerce Dr.
Exton,  PA  19341
Correspondent Contact JIM MEIKLE
Regulation Number882.4300
Classification Product Code
HBG  
Date Received03/20/1996
Decision Date 06/05/1996
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
Recalls CDRH Recalls
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