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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 K944463
Device Name CRW-1 SYSTEM
Applicant
Radionics Software Applications, Inc.
22 Terry Ave.
Burlington,  MA  01803 -2591
Applicant Contact LINDA JALBERT
Correspondent
Radionics Software Applications, Inc.
22 Terry Ave.
Burlington,  MA  01803 -2591
Correspondent Contact LINDA JALBERT
Regulation Number882.4560
Classification Product Code
HAW  
Date Received09/12/1994
Decision Date 10/26/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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