PROFILE SWAB CAT.#5273 & 5274— 510(k) K802004

Name: FDA 510(k) clearance K802004
Creator: U.S. Food and Drug Administration
Published: 1980-09-16

Substantially Equivalent

Pollak (Intl.), Ltd.

FDA 510(k) clearance K802004 for PROFILE SWAB CAT.#5273 & 5274, Substantially Equivalent on 1980-09-16. Applicant: Pollak (Intl.), Ltd.. Device class: 1.

Clearance details

Applicant: Pollak (Intl.), Ltd.
Product code: Code KXG
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: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KXG

product code KXG

Injury: 290
Total: 290

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.