The following data is part of a premarket notification filed by Ri Mos. S.r.l. with the FDA for Rampipella, Singe Port (720196) & Wedge-shaped Port (720217).
| Device ID | K991895 |
| 510k Number | K991895 |
| Device Name: | RAMPIPELLA, SINGE PORT (720196) & WEDGE-SHAPED PORT (720217) |
| Classification | Curette, Suction, Endometrial (and Accessories) |
| Applicant | RI MOS. S.R.L. 100 MAIN ST. SUITE 120 Concord, MA 01742 |
| Contact | James Delaney |
| Correspondent | James Delaney 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 | 1999-06-03 |
| Decision Date | 1999-08-12 |
| Summary: | summary |