The following data is part of a premarket notification filed by Kendall with the FDA for Acute And Chronic Catheter Repair Kit.
| Device ID | K092797 |
| 510k Number | K092797 |
| Device Name: | ACUTE AND CHRONIC CATHETER REPAIR KIT |
| Classification | Kit, Repair, Catheter, Hemodialysis |
| Applicant | KENDALL 15 HAMPSHIRE ST. Mansfield, MA 02048 |
| Contact | Daniel Campion |
| Correspondent | Daniel Campion KENDALL 15 HAMPSHIRE ST. Mansfield, MA 02048 |
| Product Code | NFK |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-11 |
| Decision Date | 2009-11-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521056282 | K092797 | 000 |