The following data is part of a premarket notification filed by Cook, Inc. with the FDA for Uldall Double Lumen Hemodialysis Catheter Set/tray.
| Device ID | K913468 |
| 510k Number | K913468 |
| Device Name: | ULDALL DOUBLE LUMEN HEMODIALYSIS CATHETER SET/TRAY |
| Classification | Catheter, Subclavian |
| Applicant | COOK, INC. 925 SOUTH CURRY PIKE P.O. BOX 489 Bloomington, IN 47402 |
| Contact | April Lavender |
| Correspondent | April Lavender COOK, INC. 925 SOUTH CURRY PIKE P.O. BOX 489 Bloomington, IN 47402 |
| Product Code | LFJ |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-05 |
| Decision Date | 1994-03-24 |