K230746
- 510(k) number
- K230746
- Device name
- Non absorbable Surgical Polypropylene Suture
- Applicant
- Shandong Haidike Medical Products Co., Ltd. CN
- Product code
- GAW — Suture, Nonabsorbable, Synthetic, Polypropylene
- Decision date
- 2023-09-14
- Date received
- 2023-03-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K230746.pdf
Official FDA record: K230746
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.