The following data is part of a premarket notification filed by Alcon Laboratories with the FDA for K-sol(tm).
| Device ID | K911587 |
| 510k Number | K911587 |
| Device Name: | K-SOL(TM) |
| Classification | System, Perfusion, Kidney |
| Applicant | ALCON LABORATORIES 6201 SOUTH FREEWAY R7-14 Fort Worth, TX 76134 -2099 |
| Contact | Denise E Mceachern |
| Correspondent | Denise E Mceachern ALCON LABORATORIES 6201 SOUTH FREEWAY R7-14 Fort Worth, TX 76134 -2099 |
| Product Code | KDN |
| CFR Regulation Number | 876.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-09 |
| Decision Date | 1991-11-01 |