K232216
- 510(k) number
- K232216
- Device name
- Hemoblock_S (Prescription); Hemoblock_S (OTC)
- Applicant
- Incore Co., Ltd. KR
- Product code
- QSY — Hemostatic Wound Dressing Without Thrombin Or Other
- Decision date
- 2024-04-19
- Date received
- 2023-07-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
510(k) Summary (official FDA PDF): K232216.pdf
Official FDA record: K232216
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.