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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name generator, high-voltage, x-ray, diagnostic
510(k) Number K945668
Device Name KXO-80G
Original Applicant
2441 michelle dr.
p.o. box 2068
tustin,  CA  92781 -2068
Original Contact javad seyedzadeh
Regulation Number892.1700
Classification Product Code
Date Received11/17/1994
Decision Date 12/27/1994
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No