BREATHABLE OVERWRAY BANDAGE NON-ELAS— 510(k) K833731

Name: FDA 510(k) clearance K833731
Creator: U.S. Food and Drug Administration
Published: 1984-01-27

Substantially Equivalent

American Medical Disposable, Inc.

FDA 510(k) clearance K833731 for BREATHABLE OVERWRAY BANDAGE NON-ELAS, Substantially Equivalent on 1984-01-27. Applicant: American Medical Disposable, Inc.. Device class: 1.

Clearance details

Applicant: American Medical Disposable, Inc.
Product code: Code KGX
Device class: Class 1
Regulation: 21 CFR 880.5240
Advisory panel: General Hospital
Date received: 1983-10-25
Decision date: 1984-01-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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More clearances from American Medical Disposable, Inc.

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K833734 — NEUROLOGICAL SPONGE ON PLASTIC STICK1984-04-23
K833735 — AN ODOR ABSORBENT BANDAGE1984-04-23
K833730 — NON ADHERENT BANDAGE/SHEET1984-01-27
K833729 — ELASTIC BREATHABLE OVER-WRAP BANDAGE1983-12-30
K833733 — NON - ADHERENT BANDAGE1983-12-27

Adverse events under product code KGX

product code KGX

Injury: 1,590
Malfunction: 1,357
Other: 3
Total: 2,950

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.