DUPAQUE SPONGE— 510(k) K941217

Name: FDA 510(k) clearance K941217
Creator: U.S. Food and Drug Administration
Published: 1994-04-21

Substantially Equivalent

Dumex Medical Surgical Products, Ltd.

FDA 510(k) clearance K941217 for DUPAQUE SPONGE, Substantially Equivalent on 1994-04-21. Applicant: Dumex Medical Surgical Products, Ltd.. Device class: 1.

Clearance details

Applicant: Dumex Medical Surgical Products, Ltd.
Product code: Code GDY
Device class: Class 1
Regulation: 21 CFR 878.4450
Advisory panel: General, Plastic Surgery
Date received: 1994-03-14
Decision date: 1994-04-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Toronto, Orntario, CA

Download summary PDF View on FDA.gov ↗

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K980779 — THALAFIX NATURAL SEA SALT DRESSING1998-06-26
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Adverse events under product code GDY

product code GDY

Malfunction: 764
Total: 764

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.