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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Tomography, Computed
510(k) Number K102677
Device Name BODYTOM NL 4000
Applicant
Neurologica Corporation
14 Electronics Ave.
Danvers,  MA  01923 -1011
Applicant Contact DONALD D FICKETT
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Correspondent Contact JAY KOGOMA
Regulation Number892.1750
Classification Product Code
JAK  
Date Received09/15/2010
Decision Date 03/24/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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