3-Layer Medical Face Masks (XMM3L3C), 3-Layer Medical Face Masks with ties (XMM3HT)
FDA 510(k) clearance K210772 · decided 2021-09-22
Clearance details
- K-number
- K210772
- Device name
- 3-Layer Medical Face Masks (XMM3L3C), 3-Layer Medical Face Masks with ties (XMM3HT)
- Applicant
- Vr Vertical, LLC Dba Xrgo
- Decision
- Substantially Equivalent
- Date received
- 2021-03-15
- Decision date
- 2021-09-22
- Days to decision
- 191 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
- Louisville, KY, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.