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FDA 510(k), K141997, CRIT-LINE IV SYSTEM
FDA 510(k), K141997, CRIT-LINE IV SYSTEM
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510(K) Number: K141997
Device Name: CRIT-LINE IV SYSTEM
Manufacturer: DENISE OPPERMANN
Device Classification Name: Accessories, Blood Circuit, Hemodialysis
Regulation Number: KOC
Classification Product Code: 07/23/2014
Date Received: 04/01/2015
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: CRIT-LINE IV SYSTEM
Manufacturer: DENISE OPPERMANN
Device Classification Name: Accessories, Blood Circuit, Hemodialysis
Regulation Number: KOC
Classification Product Code: 07/23/2014
Date Received: 04/01/2015
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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