510(k) K250518
- Device
- SMART M-CELL Bone Marrow Concentration System
- Applicant
- Miracell Co., Ltd.
- 510(k) number
- K250518
- Product code
- QBV
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-04-02
- Date received
- 2025-02-21
- Regulation
- 862.2050
- Classification name
- Centrifuge For Preparation Of Cell Concentrate And/Or Plasma Concentrate
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Sy Koo
- Address
- Rm. 405, 474 Dunchon-Daero, Jungwon-Gu Seoul KR
FDA Registration Numbers#
- 3007006186
- 3004421347
- 3010730876
- 3009155756
- 3021639773
- 3012942167
- 3023346439
- 3008624479
- 3021169199
- 3022320321
- 3010408396
- 3013846070
- 3005990076
- 3009435759
Source Documents#
Other 510(k) Records For Product Code QBV#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250516 | SMART M-CELL PRP Concentration System | Miracell Co., Ltd. | 2026-04-02 |