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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 K032970
Device Name ACRA-CUT XPRESS 120
Applicant
Acra Cut, Inc.
74 Spring Rd.
Amherst,  NH  03031
Applicant Contact KENNETH M NICOLL
Correspondent
Acra Cut, Inc.
74 Spring Rd.
Amherst,  NH  03031
Correspondent Contact KENNETH M NICOLL
Regulation Number882.4305
Classification Product Code
HBF  
Date Received09/23/2003
Decision Date 12/08/2003
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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