Cleared Traditional

MID LABS, INC. VIT MATE

K924222 · Medical Instrument Development Laboratories, Inc. · Ophthalmic

Jan 1993

Decision

159d

Days

Class 2

Risk

About This 510(k) Submission

K924222 is an FDA 510(k) clearance for the MID LABS, INC. VIT MATE, 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 January 27, 1993, 159 days after receiving the submission on August 21, 1992. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4150.

Submission Details

510(k) Number	K924222 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 21, 1992
Decision Date	January 27, 1993
Days to Decision	159 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Statement