Cleared Traditional

MAY ILLUMINATED/INFUSION PIC

K801411 · Cooper Medical Devices Corp. · Ophthalmic
Jul 1980
Decision
35d
Days
Class 1
Risk

About This 510(k) Submission

K801411 is an FDA 510(k) clearance for the MAY ILLUMINATED/INFUSION PIC, a Cannula, Ophthalmic (Class I — General Controls, product code HMX), submitted by Cooper Medical Devices Corp. (Mchenry, US). The FDA issued a Cleared decision on July 21, 1980, 35 days after receiving the submission on June 16, 1980. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4350.

Submission Details

510(k) Number K801411 FDA.gov
FDA Decision Cleared SESE
Date Received June 16, 1980
Decision Date July 21, 1980
Days to Decision 35 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

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

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