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FDA 510(k), K904434, SEXTON CYSTOTOMY URINE PUMP (SCUP2)
FDA 510(k), K904434, SEXTON CYSTOTOMY URINE PUMP (SCUP2)
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510(K) Number: K904434
Device Name: SEXTON CYSTOTOMY URINE PUMP (SCUP2)
Manufacturer: PHOENIX BIOENGINEERING, INC.
Device Classification Name: catheter, suprapubic (and accessories)
Regulation Number: 876.5090
Classification Product Code: KOB
Date Received: 09/28/1990
Decision Date: 02/01/1991
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: SEXTON CYSTOTOMY URINE PUMP (SCUP2)
Manufacturer: PHOENIX BIOENGINEERING, INC.
Device Classification Name: catheter, suprapubic (and accessories)
Regulation Number: 876.5090
Classification Product Code: KOB
Date Received: 09/28/1990
Decision Date: 02/01/1991
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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