Cleared Traditional

KPP PERITONEAL DIALYSATE FILTER

K803275 · Millipore Corp. · Gastroenterology & Urology

Mar 1981

Decision

74d

Days

Class 2

Risk

About This 510(k) Submission

K803275 is an FDA 510(k) clearance for the KPP PERITONEAL DIALYSATE FILTER, a Peritoneal Dialysate Filter (Class II — Special Controls, product code KPP), submitted by Millipore Corp. (Mchenry, US). The FDA issued a Cleared decision on March 13, 1981, 74 days after receiving the submission on December 29, 1980. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5630.

Submission Details

510(k) Number	K803275 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 29, 1980
Decision Date	March 13, 1981
Days to Decision	74 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	—