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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
Recalls CDRH Recalls
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