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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Nuclear Magnetic Resonance Imaging
510(k) Number K981398
Device Name ANATOMARK NONINVASIVE HEAD REFERENCE SYSTEM
Applicant
INTERNEURON PHARMACEUTICALS, INC.
99 HAYDEN AVE., SUITE 200
LEXINGTON,  MA  02421 -7966
Applicant Contact SONJA LOAR
Correspondent
INTERNEURON PHARMACEUTICALS, INC.
99 HAYDEN AVE., SUITE 200
LEXINGTON,  MA  02421 -7966
Correspondent Contact SONJA LOAR
Regulation Number892.1000
Classification Product Code
LNH  
Date Received04/17/1998
Decision Date 06/01/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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