510(k) K173501
- Device
- Meridian Vaginal Positioning System (VPS)
- Applicant
- Coloplast
- 510(k) number
- K173501
- Product code
- PWK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-02-09
- Date received
- 2017-11-13
- Regulation
- 884.4910
- Classification name
- Instrumentation, Surgical Mesh, Urogynecologic, Transabdominal Repair Of Pelvic Organ Prolapse
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Diane Brinza
- Address
- 1601 W. River Rd. N. Plymouth MN US 55411 55411
FDA Registration Numbers#
- 2183744
- 3032906574
- 2125050
Source Documents#
Legacy Summary#
summary
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases