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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
Predetermined Change
Control Plan Authorized		 No
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