Cleared Traditional

ENEMA SET

K771792 · Chase Mfg. Co. · Gastroenterology & Urology
Oct 1977
Decision
28d
Days
Class 1
Risk

About This 510(k) Submission

K771792 is an FDA 510(k) clearance for the ENEMA SET, a Enema Kit (Class I — General Controls, product code FCE), submitted by Chase Mfg. Co. (Mchenry, US). The FDA issued a Cleared decision on October 20, 1977, 28 days after receiving the submission on September 22, 1977. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5210.

Submission Details

510(k) Number K771792 FDA.gov
FDA Decision Cleared SESE
Date Received September 22, 1977
Decision Date October 20, 1977
Days to Decision 28 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary —

Device Classification

Product Code FCE — Enema Kit
Device Class Class I — General Controls
CFR Regulation 21 CFR 876.5210
Definition This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html.this Type Of Convenience Kit, As Listed In The Guidance Above, Is Under Enforcement Discretion, And Does Not Require A Premarket Notification (510(k)) To Market If It Meets All Criteria In The Guidance.