The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Bard Ventralex Hernia Patch, Models 0010302, 0010301.
| Device ID | K021736 |
| 510k Number | K021736 |
| Device Name: | BARD VENTRALEX HERNIA PATCH, MODELS 0010302, 0010301 |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | C.R. BARD, INC. 100 SOCKANOSSETT CROSSROAD Canston, RI 02920 |
| Contact | Brain A Kanerviko |
| Correspondent | Brain A Kanerviko C.R. BARD, INC. 100 SOCKANOSSETT CROSSROAD Canston, RI 02920 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-28 |
| Decision Date | 2002-07-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10801741016483 | K021736 | 000 |
| 10801741016476 | K021736 | 000 |