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FDA 510(k), K203717, Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0
FDA 510(k), K203717, Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0
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510(K) Number: K203717
Device Name: Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0
Manufacturer: FUJIFILM Corporaton
Device Classification Name: laparoscope, general & plastic surgery
Regulation Number: 876.1500
Classification Product Code: GCJ
Date Received: 12/21/2020
Decision Date: 06/30/2021
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0
Manufacturer: FUJIFILM Corporaton
Device Classification Name: laparoscope, general & plastic surgery
Regulation Number: 876.1500
Classification Product Code: GCJ
Date Received: 12/21/2020
Decision Date: 06/30/2021
Regulation Medical Specialty: Gastroenterology/Urology
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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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