The following data is part of a premarket notification filed by Cook, Inc. with the FDA for Modification To Uldall Double Lumen Hemodialysis Catheter Set And Tray.
| Device ID | K982333 |
| 510k Number | K982333 |
| Device Name: | MODIFICATION TO ULDALL DOUBLE LUMEN HEMODIALYSIS CATHETER SET AND TRAY |
| Classification | Catheter, Hemodialysis, Implanted |
| 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 | MSD |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-02 |
| Decision Date | 1999-02-12 |
| Summary: | summary |