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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 K902450
Device Name BODYLOG ENHANCED STRESS REDUCTION PACKAGE
Applicant
BODYLOG, INC.
COLUMBIA SQUARE
555 THIRTEENTH STREET, N.W.
WASHINGTON,  DC  20004
Applicant Contact M HOLSTEIN
Correspondent
BODYLOG, INC.
COLUMBIA SQUARE
555 THIRTEENTH STREET, N.W.
WASHINGTON,  DC  20004
Correspondent Contact M HOLSTEIN
Regulation Number882.5050
Classification Product Code
HCC  
Date Received06/01/1990
Decision Date 01/25/1991
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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