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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 K790746
Device Name THE BIONIC EXERCISER
Applicant
SCUDDER MOLNER INSTRUMENTS
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
SCUDDER MOLNER INSTRUMENTS
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number882.5050
Classification Product Code
HCC  
Date Received04/16/1979
Decision Date 05/14/1979
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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