The following data is part of a premarket notification filed by Generic Medical Device, Inc. with the FDA for Gmd Universal Sling, Model Product Code 1010 And 1020.
| Device ID | K083471 |
| 510k Number | K083471 |
| Device Name: | GMD UNIVERSAL SLING, MODEL PRODUCT CODE 1010 AND 1020 |
| Classification | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator |
| Applicant | GENERIC MEDICAL DEVICE, INC. 5727 BAKER WAY NW STE 201 Gig Harbor, WA 98332 |
| Contact | Monica Montanez |
| Correspondent | Monica Montanez GENERIC MEDICAL DEVICE, INC. 5727 BAKER WAY NW STE 201 Gig Harbor, WA 98332 |
| Product Code | OTN |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-24 |
| Decision Date | 2009-03-03 |
| Summary: | summary |