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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 (Compound, Powered)
510(k) Number K833266
Device Name ACRA-CUT
Applicant
Acra Cut, Inc.
979 Main St.
Acton,  MA  01720
Applicant Contact DAVID L MULLIN
Correspondent
Acra Cut, Inc.
979 Main St.
Acton,  MA  01720
Correspondent Contact DAVID L MULLIN
Regulation Number882.4305
Classification Product Code
HBF  
Date Received09/21/1983
Decision Date 12/29/1983
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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