Cleared Traditional

CHESEBROUGH-PONDS KANGAROO PUMP SET W/EASY-CAP CLO

K851539 · Chesebrough-Pond'S U.S.A. Co. · Gastroenterology & Urology
Jun 1985
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K851539 is an FDA 510(k) clearance for the CHESEBROUGH-PONDS KANGAROO PUMP SET W/EASY-CAP CLO, a Tubes, Gastrointestinal (and Accessories) (Class II — Special Controls, product code KNT), submitted by Chesebrough-Pond'S U.S.A. Co. (Trumbull, US). The FDA issued a Cleared decision on June 12, 1985, 57 days after receiving the submission on April 16, 1985. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5980.

Submission Details

510(k) Number K851539 FDA.gov
FDA Decision Cleared SESE
Date Received April 16, 1985
Decision Date June 12, 1985
Days to Decision 57 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary —

Device Classification

Product Code KNT — Tubes, Gastrointestinal (and Accessories)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5980

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