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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
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