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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Biofeedback
510(k) Number K870793
Device Name SELF REGULATION SYS PROF SERIES BIOFEEDBACK DEVICE
Applicant
Self Regulation Systems, Inc.
14770 NE 95th St.
Redmond,  WA  98052
Applicant Contact CARL R CHRISTINE
Correspondent
Self Regulation Systems, Inc.
14770 NE 95th St.
Redmond,  WA  98052
Correspondent Contact CARL R CHRISTINE
Regulation Number882.5050
Classification Product Code
HCC  
Date Received02/26/1987
Decision Date 05/01/1987
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
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