Freudenberg Surgical Mask
FDA 510(k) clearance K210063 · decided 2021-02-05
Clearance details
- K-number
- K210063
- Device name
- Freudenberg Surgical Mask
- Applicant
- Freudenberg Performance Materials LP
- Decision
- Substantially Equivalent
- Date received
- 2021-01-11
- Decision date
- 2021-02-05
- Days to decision
- 25 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
- Durham, NC, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.