Cleared Traditional

EMERGENCY-CLEAN UP(TM) ECP

K880306 · Cdc Products Corp. · Gastroenterology & Urology
May 1988
Decision
116d
Days
Class 1
Risk

About This 510(k) Submission

K880306 is an FDA 510(k) clearance for the EMERGENCY-CLEAN UP(TM) ECP, a Collector, Ostomy (Class I — General Controls, product code EXB), submitted by Cdc Products Corp. (Long Island City, US). The FDA issued a Cleared decision on May 20, 1988, 116 days after receiving the submission on January 25, 1988. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5900.

Submission Details

510(k) Number K880306 FDA.gov
FDA Decision Cleared SESE
Date Received January 25, 1988
Decision Date May 20, 1988
Days to Decision 116 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