The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Bard Pelvisoft Acellular Collagen Biomesh.
| Device ID | K031332 |
| 510k Number | K031332 |
| Device Name: | BARD PELVISOFT ACELLULAR COLLAGEN BIOMESH |
| Classification | Mesh, Surgical |
| Applicant | C.R. BARD, INC. 8195 INDUSTRIAL BLVD. Covington, GA 30014 |
| Contact | Terrina Wilder |
| Correspondent | Terrina Wilder C.R. BARD, INC. 8195 INDUSTRIAL BLVD. Covington, GA 30014 |
| Product Code | FTM |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-28 |
| Decision Date | 2003-05-15 |
| Summary: | summary |