The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Bard Marlex Mesh Dart.
| Device ID | K922916 |
| 510k Number | K922916 |
| Device Name: | BARD MARLEX MESH DART |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | C.R. BARD, INC. 1200 TECHNOLOGY PARK DR. P.O. BOX 7025 Billerica, MA 01821 |
| Contact | Craig M Audet |
| Correspondent | Craig M Audet C.R. BARD, INC. 1200 TECHNOLOGY PARK DR. P.O. BOX 7025 Billerica, MA 01821 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-17 |
| Decision Date | 1992-08-24 |