K221753
- 510(k) number
- K221753
- Device name
- Kangbeier Child Surgical Mask
- Applicant
- Xinxiang Kangbeier Medical Technology Co., Ltd. CN
- Product code
- OXZ — Pediatric/Child Facemask
- Decision date
- 2023-12-21
- Date received
- 2022-06-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K221753.pdf
Official FDA record: K221753
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.