The following data is part of a premarket notification filed by Kendall Healthcare Products Co. Div.of Tyco Health with the FDA for Kendall Mod. Pediatric Ultramer Polyurethane Cath..
| Device ID | K921054 |
| 510k Number | K921054 |
| Device Name: | KENDALL MOD. PEDIATRIC ULTRAMER POLYURETHANE CATH. |
| Classification | Catheter, Urological |
| Applicant | KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH 15 HAMPSHIRE ST. Mansfield, MA 02048 |
| Contact | Paul W Evans |
| Correspondent | Paul W Evans 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 | 1992-03-05 |
| Decision Date | 1992-09-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30884521016570 | K921054 | 000 |