Cleared Traditional

K904534 - ENEMA BULB
(FDA 510(k) Clearance)

K904534 · R.A.C., Inc. · Gastroenterology & Urology

Dec 1990

Decision

78d

Days

Class 1

Risk

K904534 is an FDA 510(k) clearance for the ENEMA BULB, a Enema Kit (Class I — General Controls, product code FCE), submitted by R.A.C., Inc. (Gainesville, US). The FDA issued a Cleared decision on December 21, 1990, 78 days after receiving the submission on October 4, 1990. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5210.

Submission Details

510(k) Number	K904534 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 04, 1990
Decision Date	December 21, 1990
Days to Decision	78 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.