The following data is part of a premarket notification filed by Ri Mos. S.r.l. with the FDA for Ginram Specuvag, Ginram Specuvag As, Ginram Cuscovag, Models 720101, 720102, 720103, 720179, 720227, 720043.
| Device ID | K991827 |
| 510k Number | K991827 |
| Device Name: | GINRAM SPECUVAG, GINRAM SPECUVAG AS, GINRAM CUSCOVAG, MODELS 720101, 720102, 720103, 720179, 720227, 720043 |
| Classification | Speculum, Vaginal, Nonmetal |
| Applicant | RI MOS. S.R.L. 100 MAIN ST. SUITE 120 Concord, MA 01742 |
| Contact | Adena Nora S Riemer |
| Correspondent | Adena Nora S Riemer RI MOS. S.R.L. 100 MAIN ST. SUITE 120 Concord, MA 01742 |
| Product Code | HIB |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-28 |
| Decision Date | 1999-07-19 |
| Summary: | summary |