Cleared Traditional

COLORECTAL DILATOR

K830354 · Cleveland Medical Supply & Services · Gastroenterology & Urology
May 1983
Decision
113d
Days
Class 1
Risk

About This 510(k) Submission

K830354 is an FDA 510(k) clearance for the COLORECTAL DILATOR, a Dilator, Rectal (Class I — General Controls, product code FFP), submitted by Cleveland Medical Supply & Services (Mchenry, US). The FDA issued a Cleared decision on May 27, 1983, 113 days after receiving the submission on February 3, 1983. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5450.

Submission Details

510(k) Number K830354 FDA.gov
FDA Decision Cleared SESE
Date Received February 03, 1983
Decision Date May 27, 1983
Days to Decision 113 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary —

Device Classification

Product Code FFP — Dilator, Rectal
Device Class Class I — General Controls
CFR Regulation 21 CFR 876.5450