The following data is part of a premarket notification filed by Generic Medical Device, Inc. with the FDA for Gmd Universal Urinary Incontinence Sling.
| Device ID | K111219 |
| 510k Number | K111219 |
| Device Name: | GMD UNIVERSAL URINARY INCONTINENCE SLING |
| Classification | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator |
| Applicant | GENERIC MEDICAL DEVICE, INC. PO BOX 818 Ocean Shores, WA 98569 |
| Contact | Jeff Morgan |
| Correspondent | Jeff Morgan GENERIC MEDICAL DEVICE, INC. PO BOX 818 Ocean Shores, WA 98569 |
| Product Code | OTN |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-02 |
| Decision Date | 2011-06-30 |
| Summary: | summary |