Cardinal Health Level 3 Surgical Mask with Anti-Fog Foam Strip— 510(k) K192374
Substantially EquivalentCardinal Health200, LLC
FDA 510(k) clearance K192374 for Cardinal Health Level 3 Surgical Mask with Anti-Fog Foam Strip, Substantially Equivalent on 2019-12-02. Applicant: Cardinal Health200, LLC. Device class: 2.
Clearance details
- Applicant
- Cardinal Health200, LLC
- Product code
- Code FXX
- Device class
- Class 2
- Regulation
- 21 CFR 878.4040
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Waukegan, IL, US
Recent devices under product code FXX
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- K252650 — Disposable Medical Face Mask
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- K223376 — Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110) +2 more
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Adverse events under product code FXX
product code FXX- Injury
- 137
- Total
- 137
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.