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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name cranial electrotherapy stimulator to treat insomnia and/or anxiety
510(k) Number K873920
Device Name BR-2 BIOREST
Applicant
BIOREST, INC.
P.O. BOX 171226
SAN ANTONIO,  TX  78217
Applicant Contact WM. A MENZ
Correspondent
BIOREST, INC.
P.O. BOX 171226
SAN ANTONIO,  TX  78217
Correspondent Contact WM. A MENZ
Regulation Number882.5800
Classification Product Code
QJQ  
Date Received09/25/1987
Decision Date 12/29/1987
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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