The following data is part of a premarket notification filed by Unomedical Sdn Bhd with the FDA for Silicath All Silicone Foley Catheter.
| Device ID | K945806 |
| 510k Number | K945806 |
| Device Name: | SILICATH ALL SILICONE FOLEY CATHETER |
| Classification | Catheter, Retention Type, Balloon |
| Applicant | UNOMEDICAL SDN BHD BAKAR ARANG INDUSTRIAL ESTATE P.O. BOX 18 Sungai Petani, Kedah, MY 08007 |
| Contact | Lim K Kang |
| Correspondent | Lim K Kang UNOMEDICAL SDN BHD BAKAR ARANG INDUSTRIAL ESTATE P.O. BOX 18 Sungai Petani, Kedah, MY 08007 |
| Product Code | EZL |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-28 |
| Decision Date | 1995-03-21 |