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FDA 510(k), K031676, HOMECHOICE APD SET WITH LINEO CONNECTOR, MODELS 5C4469Q, 5C4468Q, 5C4531Q, 5C8302Q, 5C4599Q
FDA 510(k), K031676, HOMECHOICE APD SET WITH LINEO CONNECTOR, MODELS 5C4469Q, 5C4468Q, 5C4531Q, 5C8302Q, 5C4599Q
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510(K) Number: K031676
Device Name: HOMECHOICE APD SET WITH LINEO CONNECTOR, MODELS 5C4469Q, 5C4468Q, 5C4531Q, 5C8302Q, 5C4599Q
Manufacturer: BAXTER HEALTHCARE CORP.
Device Classification Name: set, administration, for peritoneal dialysis, disposable
Regulation Number: 876.5630
Classification Product Code: KDJ
Date Received: 05/30/2003
Decision Date: 11/20/2003
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: HOMECHOICE APD SET WITH LINEO CONNECTOR, MODELS 5C4469Q, 5C4468Q, 5C4531Q, 5C8302Q, 5C4599Q
Manufacturer: BAXTER HEALTHCARE CORP.
Device Classification Name: set, administration, for peritoneal dialysis, disposable
Regulation Number: 876.5630
Classification Product Code: KDJ
Date Received: 05/30/2003
Decision Date: 11/20/2003
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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