The following data is part of a premarket notification filed by Generic Medical Device, Inc. with the FDA for Universal Surgical Mesh, Model 100.
| Device ID | K070018 |
| 510k Number | K070018 |
| Device Name: | UNIVERSAL SURGICAL MESH, MODEL 100 |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | GENERIC MEDICAL DEVICE, INC. 3906 ROSELAND ST. Houston, TX 77006 |
| Contact | Monica R Montanez |
| Correspondent | Monica R Montanez GENERIC MEDICAL DEVICE, INC. 3906 ROSELAND ST. Houston, TX 77006 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-03 |
| Decision Date | 2007-04-27 |
| Summary: | summary |