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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 (Simple, Powered)
510(k) Number K902703
Device Name CRANIOTOME BLADE OR DRILL BIT
Applicant
A. Henniss
18321 Ventura Blvd.,
Suite 1010
Tarzana,  CA  91356
Applicant Contact GEORGE SHECTER
Correspondent
A. Henniss
18321 Ventura Blvd.,
Suite 1010
Tarzana,  CA  91356
Correspondent Contact GEORGE SHECTER
Regulation Number882.4310
Classification Product Code
HBE  
Date Received06/20/1990
Decision Date 11/13/1990
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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