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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 K072983
FOIA Releasable 510(k) K072983
Device Name SATURN 9000-750
Applicant
New Medical Co., Ltd.
4f, #42, Singzhong Rd.
Neihu District
Taipei,  TW 114
Applicant Contact YOUNG-HOON SHIN
Correspondent
New Medical Co., Ltd.
4f, #42, Singzhong Rd.
Neihu District
Taipei,  TW 114
Correspondent Contact YOUNG-HOON SHIN
Regulation Number892.1680
Classification Product Code
MQB  
Date Received10/23/2007
Decision Date 11/13/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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