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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name device, aversive conditioning
510(k) Number K911820
Device Name GED (GRADUATED ELECTRONIC DECELERATOR
Applicant
BEHAVIOR RESEARCH INSTITUTE, INC.
240 LABAN ST.
PROVIDENCE,  RI  02909
Applicant Contact MAUREEN FOGARTY
Correspondent
BEHAVIOR RESEARCH INSTITUTE, INC.
240 LABAN ST.
PROVIDENCE,  RI  02909
Correspondent Contact MAUREEN FOGARTY
Regulation Number882.5235
Classification Product Code
HCB  
Date Received04/24/1991
Decision Date 12/05/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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