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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 K850534
Device Name BSI MODEL MCT 7000-THERMAL IMAGING SYSTEM
Applicant
Bales Scientific, Inc.
10 Middle Rd.
Lafayette,  CA  94549
Applicant Contact MAURICE J BALES
Correspondent
Bales Scientific, Inc.
10 Middle Rd.
Lafayette,  CA  94549
Correspondent Contact MAURICE J BALES
Regulation Number884.2980
Classification Product Code
LHQ  
Date Received02/11/1985
Decision Date 02/27/1985
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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