The following data is part of a premarket notification filed by Kendall Healthcare Products Co. Div.of Tyco Health with the FDA for Kendall Flat/round & Flat Splittable Silicon Drain.
| Device ID | K925748 |
| 510k Number | K925748 |
| Device Name: | KENDALL FLAT/ROUND & FLAT SPLITTABLE SILICON DRAIN |
| Classification | Catheter, Irrigation |
| Applicant | KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH 15 HAMPSHIRE ST. Mansfield, MA 02048 |
| Contact | John J Vozella |
| Correspondent | John J Vozella KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH 15 HAMPSHIRE ST. Mansfield, MA 02048 |
| Product Code | GBX |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-13 |
| Decision Date | 1993-01-13 |