The following data is part of a premarket notification filed by Deroyal with the FDA for Exac-temp Foley Catheter And Clini-temp Foley Catheter.
| Device ID | K041416 |
| 510k Number | K041416 |
| Device Name: | EXAC-TEMP FOLEY CATHETER AND CLINI-TEMP FOLEY CATHETER |
| Classification | Catheter, Upper Urinary Tract |
| Applicant | DEROYAL 200 DEBUSK LN. Powell, TN 37849 |
| Contact | Sharon Cook |
| Correspondent | Sharon Cook DEROYAL 200 DEBUSK LN. Powell, TN 37849 |
| Product Code | EYC |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-27 |
| Decision Date | 2004-07-02 |