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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 K843413
Device Name STRESS CONTROL BIOFEEDBACK CARD
Applicant
Pilgrim Plastic Products Co.
278 Babcock St.
Boston,  MA  02215
Applicant Contact WILLIAM S EPSTEIN
Correspondent
Pilgrim Plastic Products Co.
278 Babcock St.
Boston,  MA  02215
Correspondent Contact WILLIAM S EPSTEIN
Regulation Number882.5050
Classification Product Code
HCC  
Date Received08/31/1984
Decision Date 11/27/1984
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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