Cleared Traditional

TURBO-FLOW INFUSION CANNULA 19 GAGE,20 GAGE,23 GAGE, 25 GAGE, MODEL 101019,101020,101023,101025

K003036 · Retinalabs.Com · Ophthalmic
Dec 2000
Decision
84d
Days
Class 1
Risk

About This 510(k) Submission

K003036 is an FDA 510(k) clearance for the TURBO-FLOW INFUSION CANNULA 19 GAGE,20 GAGE,23 GAGE, 25 GAGE, MODEL 101019,101020,101023,101025, a Device, Irrigation, Ocular Surgery (Class I — General Controls, product code KYG), submitted by Retinalabs.Com (Atlanta, US). The FDA issued a Cleared decision on December 22, 2000, 84 days after receiving the submission on September 29, 2000. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4360.

Submission Details

510(k) Number K003036 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 2000
Decision Date December 22, 2000
Days to Decision 84 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code KYG — Device, Irrigation, Ocular Surgery
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.4360

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