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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 K932402
Device Name MODIFICATION TO GHAJAR GUIDE TWIST DRILL
Applicant
Neurodynamics, Inc.
P.O. Box 603,
Lenox Hill Station
New York,  NY  10021
Applicant Contact FATHALI GHAHREMANI
Correspondent
Neurodynamics, Inc.
P.O. Box 603,
Lenox Hill Station
New York,  NY  10021
Correspondent Contact FATHALI GHAHREMANI
Regulation Number882.4300
Classification Product Code
HBG  
Date Received04/21/1993
Decision Date 08/05/1993
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
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