The following data is part of a premarket notification filed by Madegom with the FDA for Madegom Ltda. Dental Dam.
| Device ID | K894120 |
| 510k Number | K894120 |
| Device Name: | MADEGOM LTDA. DENTAL DAM |
| Classification | Dam, Rubber |
| 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 | EIE |
| CFR Regulation Number | 872.6300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-06-12 |
| Decision Date | 1989-08-21 |