The following data is part of a premarket notification filed by Ethicon, Inc. with the FDA for Vicryl * Mesh Bag.
| Device ID | K051701 |
| 510k Number | K051701 |
| Device Name: | VICRYL * MESH BAG |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | ETHICON, INC. ROUTE 22 WEST Somerville, NJ 08876 |
| Contact | Jennifer Paine |
| Correspondent | Jennifer Paine ETHICON, INC. ROUTE 22 WEST Somerville, NJ 08876 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-24 |
| Decision Date | 2005-09-29 |
| Summary: | summary |