Cleared Traditional

INTERTIP INFUSION SET

K934204 · Oasis Medical, Inc. · Ophthalmic
Feb 1994
Decision
161d
Days
Class 2
Risk

About This 510(k) Submission

K934204 is an FDA 510(k) clearance for the INTERTIP INFUSION SET, a Instrument, Vitreous Aspiration And Cutting, Ac-powered (Class II — Special Controls, product code HQE), submitted by Oasis Medical, Inc. (Glendora, US). The FDA issued a Cleared decision on February 7, 1994, 161 days after receiving the submission on August 30, 1993. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4150.

Submission Details

510(k) Number K934204 FDA.gov
FDA Decision Cleared SESE
Date Received August 30, 1993
Decision Date February 07, 1994
Days to Decision 161 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement

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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