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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name solid state x-ray imager (flat panel/digital imager)
510(k) Number K110210
Device Name SATURN 8000-GS
Applicant
NEW MEDICAL CO., LTD.
1460 ATTERBURY DR.
WALNUT,  CA  91789
Applicant Contact JUN-HSIUNG LIN
Correspondent
NEW MEDICAL CO., LTD.
1460 ATTERBURY DR.
WALNUT,  CA  91789
Correspondent Contact JUN-HSIUNG LIN
Regulation Number892.1680
Classification Product Code
MQB  
Date Received01/25/2011
Decision Date 04/20/2011
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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