The following data is part of a premarket notification filed by Medovations, Inc. with the FDA for Urethal Catheter.
| Device ID | K874309 |
| 510k Number | K874309 |
| Device Name: | URETHAL CATHETER |
| Classification | Collector, Urine, (and Accessories) For Indwelling Catheter |
| Applicant | MEDOVATIONS, INC. 102 EAST KEEFE AVE. Milwaukee, WI 53212 |
| Contact | Larry R Pierce |
| Correspondent | Larry R Pierce MEDOVATIONS, INC. 102 EAST KEEFE AVE. Milwaukee, WI 53212 |
| Product Code | KNX |
| CFR Regulation Number | 876.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-10-20 |
| Decision Date | 1987-12-07 |