Cleared Traditional

K882878 - ODOR-END EMERGENCY CLEAN UP POWDER
(FDA 510(k) Clearance)

K882878 · Cdc Products Corp. · Gastroenterology & Urology
Dec 1988
Decision
150d
Days
Class 1
Risk

K882878 is an FDA 510(k) clearance for the ODOR-END EMERGENCY CLEAN UP POWDER. This device is classified as 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 December 8, 1988, 150 days after receiving the submission on July 11, 1988.

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

Submission Details

510(k) Number K882878 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 1988
Decision Date December 08, 1988
Days to Decision 150 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