The following data is part of a premarket notification filed by Ethicon Inc. with the FDA for Proceed Surgical Mesh.
| Device ID | K060713 |
| 510k Number | K060713 |
| Device Name: | PROCEED SURGICAL MESH |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | ETHICON INC. ROUTE 22 WEST PO BOX 151 Somerville, NJ 08876 |
| Contact | Sergio J Gadaleta |
| Correspondent | Sergio J Gadaleta ETHICON INC. ROUTE 22 WEST PO BOX 151 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 | 2006-03-17 |
| Decision Date | 2006-05-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10705031047792 | K060713 | 000 |
| 10705031047709 | K060713 | 000 |
| 10705031047716 | K060713 | 000 |
| 10705031047723 | K060713 | 000 |
| 10705031047730 | K060713 | 000 |
| 10705031047747 | K060713 | 000 |
| 10705031047754 | K060713 | 000 |
| 10705031047761 | K060713 | 000 |
| 10705031047778 | K060713 | 000 |
| 10705031047785 | K060713 | 000 |
| 10705031047693 | K060713 | 000 |