The following data is part of a premarket notification filed by Wembley Rubber Products (m) Sdn Bhd with the FDA for Wrp Foleycath.
| Device ID | K903777 |
| 510k Number | K903777 |
| Device Name: | WRP FOLEYCATH |
| Classification | Catheter, Retention Type, Balloon |
| Applicant | WEMBLEY RUBBER PRODUCTS (M) SDN BHD PERU BANDAR BARU SALAK TINGGI 43900 SEPANG Selangor, Malaysia, MY |
| Contact | Eng Keat |
| Correspondent | Eng Keat WEMBLEY RUBBER PRODUCTS (M) SDN BHD PERU BANDAR BARU SALAK TINGGI 43900 SEPANG Selangor, Malaysia, MY |
| Product Code | EZL |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-20 |
| Decision Date | 1990-12-13 |