The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Ventralight (tm) St Mesh With Echo Ps (tm) Positioning System.
| Device ID | K110820 |
| 510k Number | K110820 |
| Device Name: | VENTRALIGHT (TM) ST MESH WITH ECHO PS (TM) POSITIONING SYSTEM |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | C.R. BARD, INC. 100 CROSSINGS BOULEVARD Warwick, RI 02886 |
| Contact | Keti Sino |
| Correspondent | Keti Sino C.R. BARD, INC. 100 CROSSINGS BOULEVARD Warwick, RI 02886 |
| Product Code | FTL |
| Subsequent Product Code | GCJ |
| Subsequent Product Code | OQL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-23 |
| Decision Date | 2011-04-01 |
| Summary: | summary |