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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 K100703
Device Name STATIONARY X-RAY SYSTEM (DETECTOR) MODEL: ALTAS
Applicant
COMED CO., LTD
49 CANDLEWOOD WAY
BUENA PARK,  CA  90621
Applicant Contact BRANDON CHOI
Correspondent
COMED CO., LTD
49 CANDLEWOOD WAY
BUENA PARK,  CA  90621
Correspondent Contact BRANDON CHOI
Regulation Number892.1680
Classification Product Code
MQB  
Date Received03/12/2010
Decision Date 12/21/2010
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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