EYE APPLICATORS CAT.#980-983— 510(k) K802016

Name: FDA 510(k) clearance K802016
Creator: U.S. Food and Drug Administration
Published: 1980-09-16

Substantially Equivalent

Pollak (Intl.), Ltd.

FDA 510(k) clearance K802016 for EYE APPLICATORS CAT.#980-983, Substantially Equivalent on 1980-09-16. Applicant: Pollak (Intl.), Ltd.. Device class: 1.

Clearance details

Applicant: Pollak (Intl.), Ltd.
Product code: Code KXF
Device class: Class 1
Regulation: 21 CFR 880.6025
Advisory panel: General Hospital
Date received: 1980-08-20
Decision date: 1980-09-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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K802009 — FLOWCLAMP CAT.#1011 & 10121980-10-31
K802011 — INFUSSION ALARM SYSTEM I.A.S. CAT.#11181980-10-31

Adverse events under product code KXF

product code KXF

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.