The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Bard Crurasoft Patch, Models 0116003 & 0116001.
| Device ID | K022350 |
| 510k Number | K022350 |
| Device Name: | BARD CRURASOFT PATCH, MODELS 0116003 & 0116001 |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | C.R. BARD, INC. 100 SOCKANOSSETT CROSSROAD P.O. BOX 8500 Cranston, RI 02920 |
| Contact | Brian A Kanerviko |
| Correspondent | Brian A Kanerviko C.R. BARD, INC. 100 SOCKANOSSETT CROSSROAD P.O. BOX 8500 Cranston, 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 | 2002-07-19 |
| Decision Date | 2002-08-23 |
| Summary: | summary |