MAY ILLUMINATED/INFUSION PIC— 510(k) K801411

Name: FDA 510(k) clearance K801411
Creator: U.S. Food and Drug Administration
Published: 1980-07-21

Substantially Equivalent

Cooper Medical Devices Corp.

FDA 510(k) clearance K801411 for MAY ILLUMINATED/INFUSION PIC, Substantially Equivalent on 1980-07-21. Applicant: Cooper Medical Devices Corp.. Device class: 1.

Clearance details

Applicant: Cooper Medical Devices Corp.
Product code: Code HMX
Device class: Class 1
Regulation: 21 CFR 886.4350
Advisory panel: Ophthalmic
Date received: 1980-06-16
Decision date: 1980-07-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code HMX

product code HMX

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.