FDA 510(k), K062061, URASSIST
FDA 510(k), K062061, URASSIST
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510(K) Number: K062061
Device Name: URASSIST
Manufacturer: PREFERRED MEDICAL DEVICES, INC.
Device Classification Name: collector, urine, powered, non indwelling catheter
Regulation Number: 876.5250
Classification Product Code: NZU
Date Received: 07/20/2006
Decision Date: 10/05/2006
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: URASSIST
Manufacturer: PREFERRED MEDICAL DEVICES, INC.
Device Classification Name: collector, urine, powered, non indwelling catheter
Regulation Number: 876.5250
Classification Product Code: NZU
Date Received: 07/20/2006
Decision Date: 10/05/2006
Regulation Medical Specialty: Gastroenterology/Urology
- 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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