The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Ventrio Light Hernia Patch With Trm Antimicrobial Coating.
| Device ID | K113229 |
| 510k Number | K113229 |
| Device Name: | VENTRIO LIGHT HERNIA PATCH WITH TRM ANTIMICROBIAL COATING |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | C.R. BARD, INC. 100 CROSSINGS BOULEVARD Warwick, RI 02886 |
| Contact | Stephanie Baker |
| Correspondent | Stephanie Baker 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 | Yes |
| Date Received | 2011-11-02 |
| Decision Date | 2012-07-20 |
| Summary: | summary |