The following data is part of a premarket notification filed by Kendall Healthcare Products Co. Div.of Tyco Health with the FDA for Kendall Curity 100% Silicone Foley Catheter W/temperature Sensor.
| Device ID | K933400 |
| 510k Number | K933400 |
| Device Name: | KENDALL CURITY 100% SILICONE FOLEY CATHETER W/TEMPERATURE SENSOR |
| 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 | 1993-07-12 |
| Decision Date | 1993-11-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521149212 | K933400 | 000 |
| 20884521149202 | K933400 | 000 |
| 10884521149199 | K933400 | 000 |
| 20884521174839 | K933400 | 000 |
| 20884521057774 | K933400 | 000 |
| 15019517061833 | K933400 | 000 |
| 15019517061826 | K933400 | 000 |