PointCore Surgical Mask
FDA 510(k) clearance K220944 · decided 2022-09-09
Clearance details
- K-number
- K220944
- Device name
- PointCore Surgical Mask
- Applicant
- Pointcore, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-03-31
- Decision date
- 2022-09-09
- Days to decision
- 162 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
- Peoria, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.