Cleared Traditional

INAMED RHEMO-D (TM) DILATOR

K894618 · Inamed Development Co. · Gastroenterology & Urology
Jan 1990
Decision
182d
Days
Class 1
Risk

About This 510(k) Submission

K894618 is an FDA 510(k) clearance for the INAMED RHEMO-D (TM) DILATOR, a Dilator, Rectal (Class I — General Controls, product code FFP), submitted by Inamed Development Co. (Carpinteria, US). The FDA issued a Cleared decision on January 18, 1990, 182 days after receiving the submission on July 20, 1989. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5450.

Submission Details

510(k) Number K894618 FDA.gov
FDA Decision Cleared SESE
Date Received July 20, 1989
Decision Date January 18, 1990
Days to Decision 182 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