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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
Applicant Contact NICHOLE RIEK
Correspondent
Radionics, Inc.
22 Terry Ave.
Burlington,  MA  01803
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
Predetermined Change
Control Plan Authorized		 No
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