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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name image-intensified fluoroscopic x-ray system, mobile
510(k) Number K760429
Device Name FLOUROSCOPE, MOBILE C-ARM IMAGE INTENS.
Applicant
VARIAN ASSOC., INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
VARIAN ASSOC., INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number892.1650
Classification Product Code
OXO  
Date Received08/13/1976
Decision Date 08/23/1976
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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