The following data is part of a premarket notification filed by Ethicon, Inc. with the FDA for Ultrapro Plug.
| Device ID | K070224 |
| 510k Number | K070224 |
| Device Name: | ULTRAPRO PLUG |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | ETHICON, INC. U.S. ROUTE 22, WEST P.O. BOX 151 Somerville, NJ 08876 -0151 |
| Contact | Bryan A Lisa |
| Correspondent | Bryan A Lisa ETHICON, INC. U.S. ROUTE 22, WEST P.O. BOX 151 Somerville, NJ 08876 -0151 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-24 |
| Decision Date | 2007-04-17 |
| Summary: | summary |