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510(k) K121293

CS-SERIES-FP WITH 3030+OPTION by Omega Medical Imaging, LLC — Product Code JAA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 2012
Date Received
April 30, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Fluoroscopic, Image-Intensified
Device Class
Class II
Regulation Number
892.1650
Review Panel
RA
Submission Type

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