The following data is part of a premarket notification filed by Kendall Healthcare Products Co. Div.of Tyco Health with the FDA for Kendall Pediatric Ultramer Polyurethane Catheter.
| Device ID | K911242 |
| 510k Number | K911242 |
| Device Name: | KENDALL PEDIATRIC ULTRAMER POLYURETHANE CATHETER |
| Classification | Catheter, Urological |
| 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 | KOD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-21 |
| Decision Date | 1991-04-25 |