K243721
- 510(k) number
- K243721
- Device name
- Self Sealing Sterilization Pouches
- Applicant
- Wellmed Dental Medical Supply Co., Ltd. CN
- Product code
- FRG — Wrap, Sterilization
- Decision date
- 2025-04-25
- Date received
- 2024-12-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K243721
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.