The following data is part of a premarket notification filed by Ri Mos. S.r.l. with the FDA for Ginram Endocic Single Oval Port (model No. 720195).
| Device ID | K992926 |
| 510k Number | K992926 |
| Device Name: | GINRAM ENDOCIC SINGLE OVAL PORT (MODEL NO. 720195) |
| Classification | Curette, Suction, Endometrial (and Accessories) |
| Applicant | RI MOS. S.R.L. 100 MAIN ST. SUITE 120 Concord, MA 01742 |
| Contact | Adena S Riemer |
| Correspondent | Adena S Riemer RI MOS. S.R.L. 100 MAIN ST. SUITE 120 Concord, MA 01742 |
| Product Code | HHK |
| CFR Regulation Number | 884.1175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-31 |
| Decision Date | 1999-10-26 |
| Summary: | summary |