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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electroconvulsive therapy device for catatonia, major depressive disorder, and bipolar disorder
510(k) Number K860467
FOIA Releasable 510(k) K860467
Device Name ELECTROSHOCK UNIT NEUROLOGY MODEL B-25
Applicant
MEDCRAFT CORP.
433 BOSTON POST RD.
DARIEN,  CT  06820
Applicant Contact CHYUNG
Correspondent
MEDCRAFT CORP.
433 BOSTON POST RD.
DARIEN,  CT  06820
Correspondent Contact CHYUNG
Regulation Number882.5940
Classification Product Code
QGH  
Date Received02/06/1986
Decision Date 11/10/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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