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FDA 510(k), K160749, CRIT-LINE III Blood Chamber II
FDA 510(k), K160749, CRIT-LINE III Blood Chamber II
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510(K) Number: K160749
Device Name: CRIT-LINE III Blood Chamber II
Manufacturer: Denise Oppermann
Device Classification Name: Accessories, Blood Circuit, Hemodialysis
Regulation Number: KOC
Classification Product Code: 03/18/2016
Date Received: 04/15/2016
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: CRIT-LINE III Blood Chamber II
Manufacturer: Denise Oppermann
Device Classification Name: Accessories, Blood Circuit, Hemodialysis
Regulation Number: KOC
Classification Product Code: 03/18/2016
Date Received: 04/15/2016
Decision Date: Substantially Equivalent (SESE)
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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