510(k) K250516 ยท QBV Centrifuge For Preparation Of Cell Concentrate And/Or Plasma Concentrate
SMART M-CELL PRP Concentration System
| Applicant | Miracell Co., Ltd., Seoul, KR |
| Decision | Substantially Equivalent, Apr 2, 2026 |
| Received | Feb 21, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250516
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.