LM Surgical Mask Level 3, LM Surgical Mask Level 2,
FDA 510(k) clearance K211378 · decided 2021-12-16
Clearance details
- K-number
- K211378
- Device name
- LM Surgical Mask Level 3, LM Surgical Mask Level 2,
- Applicant
- Liberty Mask, LLC
- Decision
- Substantially Equivalent
- Date received
- 2021-05-04
- Decision date
- 2021-12-16
- Days to decision
- 226 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
- Richardson, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.