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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 K897191
Device Name BSI MODEL TIP
Applicant
Bales Scientific, Inc.
1620 Tice Valley Blvd., #250
Walnut Creek,  CA  94595
Applicant Contact MAURICE J BALES
Correspondent
Bales Scientific, Inc.
1620 Tice Valley Blvd., #250
Walnut Creek,  CA  94595
Correspondent Contact MAURICE J BALES
Regulation Number884.2980
Classification Product Code
LHQ  
Date Received12/28/1989
Decision Date 07/13/1990
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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