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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Fluoroscopic, Image-Intensified
510(k) Number K926064
Device Name FLUOROSCOPIC BRIGHTNESS STABALIZER/FBS MODEL 9205A
Applicant
Scientific Technology , Ltd.
11845 Forestgate Dr.
Dallas,  TX  75243
Applicant Contact JAMES R HERRINGTON
Correspondent
Scientific Technology , Ltd.
11845 Forestgate Dr.
Dallas,  TX  75243
Correspondent Contact JAMES R HERRINGTON
Regulation Number892.1650
Classification Product Code
JAA  
Date Received12/01/1992
Decision Date 04/27/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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