Cleared Traditional

K840384 - DIAGNOSTIC DILATATION & MENSTRUAL KIT
(FDA 510(k) Clearance)

K840384 · Intl. Medical Technologies, Inc. · Obstetrics & Gynecology

Apr 1984

Decision

91d

Days

Class 2

Risk

K840384 is an FDA 510(k) clearance for the DIAGNOSTIC DILATATION & MENSTRUAL KIT. This device is classified as a System, Abortion, Vacuum (Class II — Special Controls, product code HHI).

Submitted by Intl. Medical Technologies, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 30, 1984, 91 days after receiving the submission on January 30, 1984.

This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5070.

Submission Details

510(k) Number	K840384 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 30, 1984
Decision Date	April 30, 1984
Days to Decision	91 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	—