Cleared Traditional

TOTAL CONTAINMENT DEVICE

K913515 · Denco · Gastroenterology & Urology

May 1994

Decision

1023d

Days

Class 2

Risk

About This 510(k) Submission

K913515 is an FDA 510(k) clearance for the TOTAL CONTAINMENT DEVICE, a System, Dialysate Delivery, Semi-automatic, Peritoneal (Class II — Special Controls, product code KPF), submitted by Denco (Wilmington, US). The FDA issued a Cleared decision on May 26, 1994, 1023 days after receiving the submission on August 7, 1991. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5630.

Submission Details

510(k) Number	K913515 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 07, 1991
Decision Date	May 26, 1994
Days to Decision	1023 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Statement