Cleared Traditional

CYBERREN

K970989 · Cybernius Medical , Ltd. · Gastroenterology & Urology

Jul 1997

Decision

128d

Days

Class 2

Risk

About This 510(k) Submission

K970989 is an FDA 510(k) clearance for the CYBERREN, a System, Dialysate Delivery, Semi-automatic, Peritoneal (Class II — Special Controls, product code KPF), submitted by Cybernius Medical , Ltd. (St. Albert, Alberta, CA). The FDA issued a Cleared decision on July 24, 1997, 128 days after receiving the submission on March 18, 1997. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5630.

Submission Details

510(k) Number	K970989 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 18, 1997
Decision Date	July 24, 1997
Days to Decision	128 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Statement