The following data is part of a premarket notification filed by S. Jackson, Inc. with the FDA for Supramesh Extra.
| Device ID | K080216 |
| 510k Number | K080216 |
| Device Name: | SUPRAMESH EXTRA |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | S. JACKSON, INC. 9109 COPERHAVER DR Potomac, MD 20854 |
| Contact | Norman R Estrin |
| Correspondent | Norman R Estrin S. JACKSON, INC. 9109 COPERHAVER DR Potomac, MD 20854 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-29 |
| Decision Date | 2008-09-15 |
| Summary: | summary |