The following data is part of a premarket notification filed by Davol Inc., Sub. C.r. Bard, Inc. with the FDA for Ventralight St Mesh.
| Device ID | K101851 |
| 510k Number | K101851 |
| Device Name: | VENTRALIGHT ST MESH |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | DAVOL INC., SUB. C.R. BARD, INC. 100 CROSSINGS BLVD Warwick, RI 02886 |
| Contact | Michelle Godin |
| Correspondent | Michelle Godin DAVOL INC., SUB. C.R. BARD, INC. 100 CROSSINGS BLVD Warwick, RI 02886 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-01 |
| Decision Date | 2010-07-15 |