Cleared Traditional

K921611 - MADAVAC 190 (FDA 510(k) Clearance)

K921611 · Mada Medical Products, Inc. · General & Plastic Surgery device

Sep 1992

Decision

159d

Days

Class 2

Risk

K921611 is an FDA 510(k) clearance for the MADAVAC 190. This device is classified as a Pump, Portable, Aspiration (manual Or Powered) (Class II - Special Controls, product code BTA).

Submitted by Mada Medical Products, Inc. (Carlstadt, US). The FDA issued a Cleared decision on September 9, 1992, 159 days after receiving the submission on April 3, 1992.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4780.

Submission Details

510(k) Number	K921611 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 03, 1992
Decision Date	September 09, 1992
Days to Decision	159 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Statement