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FDA 510(k), K141136, LEICA FL800
FDA 510(k), K141136, LEICA FL800
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510(K) Number: K141136
Device Name: LEICA FL800
Manufacturer: LEICA BIOSYSTEMS RICHMOND
Device Classification Name: system, x-ray, angiographic
Regulation Number: 892.1600
Classification Product Code: IZI
Date Received: 05/01/2014
Decision Date: 08/19/2014
Regulation Medical Specialty: Radiology
Device Name: LEICA FL800
Manufacturer: LEICA BIOSYSTEMS RICHMOND
Device Classification Name: system, x-ray, angiographic
Regulation Number: 892.1600
Classification Product Code: IZI
Date Received: 05/01/2014
Decision Date: 08/19/2014
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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