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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name tube mount, x-ray, diagnostic
510(k) Number K881701
Device Name RADKOR SFC-21
Original Applicant
16610 aston st.
irvine,  CA  92714
Original Contact jack e briggs
Regulation Number892.1770
Classification Product Code
Date Received04/19/1988
Decision Date 09/08/1988
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No