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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
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