The following data is part of a premarket notification filed by Unomedical Sdn Bhd with the FDA for Euromedical Haematuria Foley Catheter.
| Device ID | K973076 |
| 510k Number | K973076 |
| Device Name: | EUROMEDICAL HAEMATURIA FOLEY CATHETER |
| Classification | Catheter, Retention Type, Balloon |
| Applicant | UNOMEDICAL SDN BHD POST OFFICE BOX 1108 Elfers, FL 34680 |
| Contact | Patrick J Lamb |
| Correspondent | Patrick J Lamb UNOMEDICAL SDN BHD POST OFFICE BOX 1108 Elfers, FL 34680 |
| Product Code | EZL |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-18 |
| Decision Date | 1998-09-16 |
| Summary: | summary |