The following data is part of a premarket notification filed by Organ Recovery Systems, Inc. with the FDA for Kps-i, The Kidney Perfusion Solution.
| Device ID | K013575 |
| 510k Number | K013575 |
| Device Name: | KPS-I, THE KIDNEY PERFUSION SOLUTION |
| Classification | System, Perfusion, Kidney |
| Applicant | ORGAN RECOVERY SYSTEMS, INC. 701 EAST BAY ST. SUITE 433 Charleston, SC 29403 |
| Contact | Stanley J Harris |
| Correspondent | Stanley J Harris ORGAN RECOVERY SYSTEMS, INC. 701 EAST BAY ST. SUITE 433 Charleston, SC 29403 |
| Product Code | KDN |
| CFR Regulation Number | 876.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-29 |
| Decision Date | 2002-01-25 |
| Summary: | summary |