The following data is part of a premarket notification filed by Coloplast with the FDA for Meridian Vaginal Positioning System (vps).
| Device ID | K173501 |
| 510k Number | K173501 |
| Device Name: | Meridian Vaginal Positioning System (VPS) |
| Classification | Instrumentation, Surgical Mesh, Urogynecologic, Transabdominal Repair Of Pelvic Organ Prolapse |
| Applicant | Coloplast 1601 West River Road North Minneapolis, MN 55411 |
| Contact | Diane Brinza |
| Correspondent | Diane Brinza Coloplast 1601 West River Road North Minneapolis, MN 55411 |
| Product Code | PWK |
| CFR Regulation Number | 884.4910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-11-13 |
| Decision Date | 2018-02-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05708932553759 | K173501 | 000 |