The following data is part of a premarket notification filed by The Kendal Co. with the FDA for Kendall Curity Suprapubic Catheter Tray, Kit, & Replacement Set.
| Device ID | K970969 |
| 510k Number | K970969 |
| Device Name: | KENDALL CURITY SUPRAPUBIC CATHETER TRAY, KIT, & REPLACEMENT SET |
| Classification | Catheter, Suprapubic (and Accessories) |
| Applicant | THE KENDAL CO. 15 HAMPSHIRE ST. Mansfield, MA 02048 -1108 |
| Contact | David A Olson |
| Correspondent | David A Olson THE KENDAL CO. 15 HAMPSHIRE ST. Mansfield, MA 02048 -1108 |
| Product Code | KOB |
| CFR Regulation Number | 876.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-17 |
| Decision Date | 1997-04-23 |
| Summary: | summary |