K220525
- 510(k) number
- K220525
- Device name
- RESPONDER Polysaccharide Hemostat
- Applicant
- Starch Medical, Inc. CA · US
- Product code
- QSY — Hemostatic Wound Dressing Without Thrombin Or Other
- Decision date
- 2023-12-04
- Date received
- 2022-02-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K220525.pdf
Official FDA record: K220525
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.