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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
Predetermined Change
Control Plan Authorized		 No
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