Cleared Traditional

CAPD SAFELOCK TRANSFER SET W/PRE-FILLED CONNECTOR

K904806 · Fresenius USA, Inc. · Gastroenterology & Urology
Jan 1991
Decision
79d
Days
Class 2
Risk

About This 510(k) Submission

K904806 is an FDA 510(k) clearance for the CAPD SAFELOCK TRANSFER SET W/PRE-FILLED CONNECTOR, a Set, Administration, For Peritoneal Dialysis, Disposable (Class II — Special Controls, product code KDJ), submitted by Fresenius USA, Inc. (Concord, US). The FDA issued a Cleared decision on January 11, 1991, 79 days after receiving the submission on October 24, 1990. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5630.

Submission Details

510(k) Number K904806 FDA.gov
FDA Decision Cleared SESE
Date Received October 24, 1990
Decision Date January 11, 1991
Days to Decision 79 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary —

Device Classification

Product Code KDJ — Set, Administration, For Peritoneal Dialysis, Disposable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5630

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