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FDA 510(k), K181084, PENTAX Video Colonoscopes (EC Family)
FDA 510(k), K181084, PENTAX Video Colonoscopes (EC Family)
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$149.00 USD
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510(K) Number: K181084
Device Name: PENTAX Video Colonoscopes (EC Family)
Manufacturer: PENTAX of America, Inc.
Device Classification Name: colonoscope and accessories, flexible/rigid
Regulation Number: 876.1500
Classification Product Code: FDF
Date Received: 04/24/2018
Decision Date: 01/18/2019
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: PENTAX Video Colonoscopes (EC Family)
Manufacturer: PENTAX of America, Inc.
Device Classification Name: colonoscope and accessories, flexible/rigid
Regulation Number: 876.1500
Classification Product Code: FDF
Date Received: 04/24/2018
Decision Date: 01/18/2019
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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