Cardinal Health™ Level 3 Surgical Mask with Anti-Fog Foam Strip
FDA 510(k) clearance K192374 · decided 2019-12-02
Clearance details
- K-number
- K192374
- Device name
- Cardinal Health™ Level 3 Surgical Mask with Anti-Fog Foam Strip
- Applicant
- Cardinal Health200, LLC
- Decision
- Substantially Equivalent
- Date received
- 2019-08-30
- Decision date
- 2019-12-02
- Days to decision
- 94 days
- Clearance type
- Traditional
- Product code
- FXX
- Device class
- 2
- Regulation number
- 878.4040
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Waukegan, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.