K253629
- 510(k) number
- K253629
- Device name
- Momcozy Nasal Aspirator (BN007)
- Applicant
- Shenzhen Root Innovation Technology Co., Ltd. CN
- Product code
- BTA — Pump, Portable, Aspiration (Manual Or Powered)
- Decision date
- 2026-05-26
- Date received
- 2025-11-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 1.2 MB · U.S. public domain
Also available from FDA: K253629.pdf
Official FDA record: K253629
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.