The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Bard 3dmax Light Mesh, Models: 0117310, 0117311, 0117312, 0117320, 0117321, 011732.
| Device ID | K091659 |
| 510k Number | K091659 |
| Device Name: | BARD 3DMAX LIGHT MESH, MODELS: 0117310, 0117311, 0117312, 0117320, 0117321, 011732 |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | C.R. BARD, INC. 100 CROSSINGS BLVD. Warwick, RI 02886 |
| Contact | Gail Dow |
| Correspondent | Gail Dow C.R. BARD, INC. 100 CROSSINGS BLVD. 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 | 2009-06-09 |
| Decision Date | 2009-08-03 |
| Summary: | summary |