LORREX GAUZE SPONGES, X-RAY DETECTABLE— 510(k) K942366
Substantially EquivalentLorrex Health Products
FDA 510(k) clearance K942366 for LORREX GAUZE SPONGES, X-RAY DETECTABLE, Substantially Equivalent on 1994-05-27. Applicant: Lorrex Health Products.
Clearance details
- Applicant
- Lorrex Health Products
- Product code
- Code GDY
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Secaucus, NJ, US
Adverse events under product code GDY
product code GDY- Malfunction
- 764
- Total
- 764
Source: openFDA MAUDE database, through . 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.