Cleared Traditional

MID LABS AUTONOMOUS VIT ENHANCER (AVE)

K020911 · Medical Instrument Development Laboratories, Inc. · Ophthalmic

Apr 2002

Decision

40d

Days

Class 2

Risk

About This 510(k) Submission

K020911 is an FDA 510(k) clearance for the MID LABS AUTONOMOUS VIT ENHANCER (AVE), a Instrument, Vitreous Aspiration And Cutting, Ac-powered (Class II — Special Controls, product code HQE), submitted by Medical Instrument Development Laboratories, Inc. (San Leandro, US). The FDA issued a Cleared decision on April 29, 2002, 40 days after receiving the submission on March 20, 2002. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4150.

Submission Details

510(k) Number	K020911 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 20, 2002
Decision Date	April 29, 2002
Days to Decision	40 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF