POSE™ Health Care Surgical Mask
FDA 510(k) clearance K223270 · decided 2022-11-01
Clearance details
- K-number
- K223270
- Device name
- POSE™ Health Care Surgical Mask
- Applicant
- America'S Supply Chains
- Decision
- Substantially Equivalent
- Date received
- 2022-10-24
- Decision date
- 2022-11-01
- Days to decision
- 8 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
- Frisco, TX, US
- Third-party review
- Yes
- 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.