The following data is part of a premarket notification filed by Generic Medical Devices, Inc. with the FDA for Gmd Universal Urinary Incontinence Sling, Model 1012.
| Device ID | K101440 |
| 510k Number | K101440 |
| Device Name: | GMD UNIVERSAL URINARY INCONTINENCE SLING, MODEL 1012 |
| Classification | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator |
| Applicant | GENERIC MEDICAL DEVICES, INC. PO BOX 818 Ocean Shores, WA 98569 |
| Contact | Jeff Morgan |
| Correspondent | Jeff Morgan GENERIC MEDICAL DEVICES, INC. PO BOX 818 Ocean Shores, WA 98569 |
| Product Code | OTN |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-05-24 |
| Decision Date | 2010-06-18 |
| Summary: | summary |