Cleared Traditional

INTER TIP T

K934844 · Microsurgical Technology, Inc. · Ophthalmic
Apr 1994
Decision
193d
Days
Class 1
Risk

About This 510(k) Submission

K934844 is an FDA 510(k) clearance for the INTER TIP T, a Cannula, Ophthalmic (Class I — General Controls, product code HMX), submitted by Microsurgical Technology, Inc. (Kirkland, US). The FDA issued a Cleared decision on April 19, 1994, 193 days after receiving the submission on October 8, 1993. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4350.

Submission Details

510(k) Number K934844 FDA.gov
FDA Decision Cleared SESE
Date Received October 08, 1993
Decision Date April 19, 1994
Days to Decision 193 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement

Device Classification

Product Code HMX — Cannula, Ophthalmic
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.4350

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