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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Neurological Stereotaxic Instrument
510(k) Number K980584
Device Name ATLASPLAN
Applicant
RADIONICS, INC.
22 TERRY AVE.
BURLINGTON,  MA  01803 -2516
Applicant Contact NICHOLE RIEK
Correspondent
RADIONICS, INC.
22 TERRY AVE.
BURLINGTON,  MA  01803 -2516
Correspondent Contact NICHOLE RIEK
Regulation Number882.4560
Classification Product Code
HAW  
Date Received02/17/1998
Decision Date 05/18/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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