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FDA 510(k), K151620, Firefly Peritoneal Dialysis Connector Disinfection System
FDA 510(k), K151620, Firefly Peritoneal Dialysis Connector Disinfection System
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$49.00 USD
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$49.00 USD
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510(K) Number: K151620
Device Name: Firefly Peritoneal Dialysis Connector Disinfection System
Manufacturer: PURACATH MEDICAL, INC.
Device Classification Name: set, administration, for peritoneal dialysis, disposable
Regulation Number: 876.5630
Classification Product Code: KDJ
Date Received: 06/16/2015
Decision Date: 01/20/2016
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: Firefly Peritoneal Dialysis Connector Disinfection System
Manufacturer: PURACATH MEDICAL, INC.
Device Classification Name: set, administration, for peritoneal dialysis, disposable
Regulation Number: 876.5630
Classification Product Code: KDJ
Date Received: 06/16/2015
Decision Date: 01/20/2016
Regulation Medical Specialty: Gastroenterology/Urology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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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