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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 K980373
Device Name ULTRAMIND BIOFEEDBACK SYSTEM WITH DE-STRESS SOFTWARE
Applicant
ULTRAMIND INTERNATIONAL LTD.
117 AHUZAH ST.
RA'ANANNA,  IL 43373
Applicant Contact SHOSHANA FRIEDMAN
Correspondent
ULTRAMIND INTERNATIONAL LTD.
117 AHUZAH ST.
RA'ANANNA,  IL 43373
Correspondent Contact SHOSHANA FRIEDMAN
Regulation Number882.5050
Classification Product Code
HCC  
Date Received01/30/1998
Decision Date 04/29/1998
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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