The following data is part of a premarket notification filed by Institut Georges Lopez with the FDA for Perf-gen Pulsatile Perfusion Solution.
| Device ID | K221386 |
| 510k Number | K221386 |
| Device Name: | PERF-GEN Pulsatile Perfusion Solution |
| Classification | Set, Perfusion, Kidney, Disposable |
| Applicant | Institut Georges Lopez Parc Tertiaire Du Bois Dieu, 1 Allee Des Chevreuils Lissieu, FR 69380 |
| Contact | Matthieu Prouteau |
| Correspondent | Matthieu Prouteau Institut Georges Lopez Parc Tertiaire Du Bois Dieu, 1 Allee Des Chevreuils Lissieu, FR 69380 |
| Product Code | KDL |
| CFR Regulation Number | 876.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-05-13 |
| Decision Date | 2022-06-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 23700911900499 | K221386 | 000 |
| 23700911900611 | K221386 | 000 |