The following data is part of a premarket notification filed by Organ Recovery Systems, Inc. with the FDA for Modification To Kps-1, Kidney Perfusion Solutiion.
| Device ID | K022391 |
| 510k Number | K022391 |
| Device Name: | MODIFICATION TO KPS-1, KIDNEY PERFUSION SOLUTIION |
| Classification | System, Perfusion, Kidney |
| Applicant | ORGAN RECOVERY SYSTEMS, INC. 701 EAST BAY ST. SUITE 433 Charleston, SC 29466 |
| Contact | Stanley Harris |
| Correspondent | Stanley Harris ORGAN RECOVERY SYSTEMS, INC. 701 EAST BAY ST. SUITE 433 Charleston, SC 29466 |
| Product Code | KDN |
| CFR Regulation Number | 876.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-23 |
| Decision Date | 2002-10-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10815045020343 | K022391 | 000 |