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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 K080589
Device Name SATURN 9000-810
Applicant
NEW MEDICAL CO., LTD.
4F, NO.42, SINGZHONG RD.
NEIHU DISTRICT
TAIPEI,  TW 114
Applicant Contact YOUNG-HOON SHIN
Correspondent
NEW MEDICAL CO., LTD.
4F, NO.42, SINGZHONG RD.
NEIHU DISTRICT
TAIPEI,  TW 114
Correspondent Contact YOUNG-HOON SHIN
Regulation Number892.1680
Classification Product Code
MQB  
Date Received03/03/2008
Decision Date 06/11/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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