Medical Face Masks, Model Name:MY020003
FDA 510(k) clearance K211165 · decided 2021-11-09
Clearance details
- K-number
- K211165
- Device name
- Medical Face Masks, Model Name:MY020003
- Applicant
- Huizhou Jie Bai Purification Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2021-04-19
- Decision date
- 2021-11-09
- Days to decision
- 204 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
- Huizhou, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.