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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Thermographic, Liquid Crystal, Nonpowered (Adjunctive Use)
510(k) Number K900404
Device Name VARICOSCREEN(TM)
Applicant
Promedex, Inc.
C/O Richard Hamer Assoc.Inc.
P.O.Box 16598
Fort Woth,  TX  76162
Applicant Contact RICHARD A HAMER
Correspondent
Promedex, Inc.
C/O Richard Hamer Assoc.Inc.
P.O.Box 16598
Fort Woth,  TX  76162
Correspondent Contact RICHARD A HAMER
Regulation Number884.2982
Classification Product Code
KYA  
Date Received01/29/1990
Decision Date 12/07/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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