Cleared Traditional

K840383 - MENSTRUAL ASPIRATION KIT
(FDA 510(k) Clearance)

K840383 · Intl. Medical Technologies, Inc. · Obstetrics & Gynecology device

Apr 1984

Decision

91d

Days

Class 2

Risk

K840383 is an FDA 510(k) clearance for the MENSTRUAL ASPIRATION 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	K840383 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (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	—