K233111
- 510(k) number
- K233111
- Device name
- ALGS2 Ag Alginate Wound Dressing Rx; ALGS2 Ag Alginate Wound Dressing OTC; ALGS2S Re-enforced Ag Alginate Wound Dressing Rx; ALGS2S Re-enforced Ag Alginate Wound Dressing OTC
- Applicant
- Foshan United Medical Technologies, Ltd. CN
- Product code
- FRO — Dressing, Wound, Drug
- Decision date
- 2024-05-24
- Date received
- 2023-09-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K233111.pdf
Official FDA record: K233111
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.