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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 K881164
Device Name LEUNOMED RFB 5000
Applicant
HEMODYNAMICS, INC.
5301 NORTH FEDERAL HGWY.
STE. 140
BOCA RATON,  FL  33431
Applicant Contact ALAN P SCHWARTZ
Correspondent
HEMODYNAMICS, INC.
5301 NORTH FEDERAL HGWY.
STE. 140
BOCA RATON,  FL  33431
Correspondent Contact ALAN P SCHWARTZ
Regulation Number882.5050
Classification Product Code
HCC  
Date Received03/18/1988
Decision Date 04/24/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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