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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Telethermographic (Adjunctive Use)
510(k) Number K023434
Device Name DOREX SPECTRUM 9000MB THERMOGRAPHY SYSTEM
Applicant
Dorex, Inc.
954 N Lemon St.
Orange,  CA  92867
Applicant Contact MEL KUTAS
Correspondent
Dorex, Inc.
954 N Lemon St.
Orange,  CA  92867
Correspondent Contact MEL KUTAS
Regulation Number884.2980
Classification Product Code
LHQ  
Date Received10/15/2002
Decision Date 11/14/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Radiology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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