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FDA 510(k), K061871, LEICA MODEL FL800
FDA 510(k), K061871, LEICA MODEL FL800
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510(K) Number: K061871
Device Name: LEICA MODEL FL800
Manufacturer: MAX STURGIS
Device Classification Name: System, X-Ray, Angiographic
Regulation Number: IZI
Classification Product Code: 07/03/2006
Date Received: 09/20/2006
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
Device Name: LEICA MODEL FL800
Manufacturer: MAX STURGIS
Device Classification Name: System, X-Ray, Angiographic
Regulation Number: IZI
Classification Product Code: 07/03/2006
Date Received: 09/20/2006
Decision Date: Substantially Equivalent (SESE)
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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