DRESSING CHANGE TRAY-MEDIUM— 510(k) K802954

Name: FDA 510(k) clearance K802954
Creator: U.S. Food and Drug Administration
Published: 1980-12-17

Substantially Equivalent

Associated Medical Products Co.

FDA 510(k) clearance K802954 for DRESSING CHANGE TRAY-MEDIUM, Substantially Equivalent on 1980-12-17. Applicant: Associated Medical Products Co.. Device class: 2.

Clearance details

Applicant: Associated Medical Products Co.
Product code: Code FKO
Device class: Class 2
Regulation: 21 CFR 876.5630
Advisory panel: Gastroenterology, Urology
Date received: 1980-11-20
Decision date: 1980-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K930507 — CUSTOM ORTHOPAEDIC TRAYS (PACKS)1994-02-22
K932217 — MAJOR, MINOR, BASIN TRAYS (PACKS)1993-11-15
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Adverse events under product code FKO

product code FKO

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.