Cleared Traditional

I/A HANDPIECE

K850857 · Medical Instrument Development Laboratories, Inc. · Ophthalmic
Mar 1985
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K850857 is an FDA 510(k) clearance for the I/A HANDPIECE, 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 March 29, 1985, 28 days after receiving the submission on March 1, 1985. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4150.

Submission Details

510(k) Number K850857 FDA.gov
FDA Decision Cleared SESE
Date Received March 01, 1985
Decision Date March 29, 1985
Days to Decision 28 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

Product Code HQE — Instrument, Vitreous Aspiration And Cutting, Ac-powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.4150

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