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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 K911911
Device Name MEDICAL DESIGNS, INC. BIO-THERAPY SYSTEM
Applicant
Medical Design & Manufacturing Corp.
929 Eastwind Dr.
Westerville,  OH  43081
Applicant Contact H SOUTHWORTH
Correspondent
Medical Design & Manufacturing Corp.
929 Eastwind Dr.
Westerville,  OH  43081
Correspondent Contact H SOUTHWORTH
Regulation Number882.5050
Classification Product Code
HCC  
Date Received04/30/1991
Decision Date 03/20/1992
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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