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FDA 510(k), K170239, Leica FL560
FDA 510(k), K170239, Leica FL560
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510(K) Number: K170239
Device Name: Leica FL560
Manufacturer: LEICA MICROSYSTEMS (SCHWEIZ) AG
Device Classification Name: system, x-ray, angiographic
Regulation Number: 892.1600
Classification Product Code: IZI
Date Received: 01/26/2017
Decision Date: 07/05/2017
Regulation Medical Specialty: Radiology
Device Name: Leica FL560
Manufacturer: LEICA MICROSYSTEMS (SCHWEIZ) AG
Device Classification Name: system, x-ray, angiographic
Regulation Number: 892.1600
Classification Product Code: IZI
Date Received: 01/26/2017
Decision Date: 07/05/2017
Regulation Medical Specialty: Radiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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