FDA 510(k), K062061, URASSIST
FDA 510(k), K062061, URASSIST
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
Total pages: 331
Fully redacted pages: 198 (≤ 50 words or fully blacked out)
Content pages: 133
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