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FDA 510(k), K132027, OEC 9800 PLUS
FDA 510(k), K132027, OEC 9800 PLUS
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510(K) Number: K132027
Device Name: OEC 9800 PLUS
Manufacturer: GE OEC MEDICAL SYSTEMS, INC
Device Classification Name: interventional fluoroscopic x-ray system
Regulation Number: 892.1650
Classification Product Code: OWB
Date Received: 07/01/2013
Decision Date: 05/01/2014
Regulation Medical Specialty: Radiology
Device Name: OEC 9800 PLUS
Manufacturer: GE OEC MEDICAL SYSTEMS, INC
Device Classification Name: interventional fluoroscopic x-ray system
Regulation Number: 892.1650
Classification Product Code: OWB
Date Received: 07/01/2013
Decision Date: 05/01/2014
Regulation Medical Specialty: Radiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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