The following data is part of a premarket notification filed by Madegom with the FDA for Madegom Ltda. Penrose Drain Tubing.
| Device ID | K894119 |
| 510k Number | K894119 |
| Device Name: | MADEGOM LTDA. PENROSE DRAIN TUBING |
| Classification | Catheter, Peritoneal |
| Applicant | MADEGOM CASILLA POSTAL 85 11 SANTIAGO Chile, CL |
| Contact | Alejandro Miralles |
| Correspondent | Alejandro Miralles MADEGOM CASILLA POSTAL 85 11 SANTIAGO Chile, CL |
| Product Code | GBW |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-06-12 |
| Decision Date | 1989-08-18 |