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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 K801320
Device Name SFX-90 TABLE/SPOTFILMER W/FLUORICON L200
Applicant
General Electric Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
General Electric Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number892.1650
Classification Product Code
JAA  
Date Received06/03/1980
Decision Date 07/21/1980
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
Recalls CDRH Recalls
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