The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Ventralex St Hernia Patch.
| Device ID | K101928 |
| 510k Number | K101928 |
| Device Name: | VENTRALEX ST HERNIA PATCH |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | C.R. BARD, INC. 100 CROSSINGS BOULEVARD Warwick, RI 02886 |
| Contact | Michelle Godin |
| Correspondent | Michelle Godin C.R. BARD, INC. 100 CROSSINGS BOULEVARD Warwick, RI 02886 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-09 |
| Decision Date | 2011-03-23 |
| Summary: | summary |