Cleared Traditional

K833566 - COMFEEL CLEANSER (FDA 510(k) Clearance)

K833566 · Coloplast A/S · Gastroenterology & Urology device
Dec 1983
Decision
76d
Days
Class 1
Risk

K833566 is an FDA 510(k) clearance for the COMFEEL CLEANSER. This device is classified as a Collector, Ostomy (Class I - General Controls, product code EXB).

Submitted by Coloplast A/S (Mchenry, US). The FDA issued a Cleared decision on December 27, 1983, 76 days after receiving the submission on October 12, 1983.

This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5900.

Submission Details

510(k) Number K833566 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 1983
Decision Date December 27, 1983
Days to Decision 76 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary —

Device Classification

Product Code EXB — Collector, Ostomy
Device Class Class I - General Controls
CFR Regulation 21 CFR 876.5900