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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Amplifier, Physiological Signal
510(k) Number K901797
Device Name THE WONDER BOX
Applicant
MICROTRONICS CORP.
P.O. BOX 399
CARRBORO,  NC  27510
Applicant Contact JACK R SMITH
Correspondent
MICROTRONICS CORP.
P.O. BOX 399
CARRBORO,  NC  27510
Correspondent Contact JACK R SMITH
Regulation Number882.1835
Classification Product Code
GWL  
Date Received04/19/1990
Decision Date 02/07/1991
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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