STRUNG NEURO SPONGE PATTIES-X-RAY-— 510(k) K831914

Name: FDA 510(k) clearance K831914
Creator: U.S. Food and Drug Administration
Published: 1983-10-31

Substantially Equivalent

Ormed Mfg., Inc.

FDA 510(k) clearance K831914 for STRUNG NEURO SPONGE PATTIES-X-RAY-, Substantially Equivalent on 1983-10-31. Applicant: Ormed Mfg., Inc.. Device class: 1.

Clearance details

Applicant: Ormed Mfg., Inc.
Product code: Code GDY
Device class: Class 1
Regulation: 21 CFR 878.4450
Advisory panel: General, Plastic Surgery
Date received: 1983-06-14
Decision date: 1983-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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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.