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 |