The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Bard Ck Parastomal Hernia Patch, Models 0118001, 0118002, 0118003, 0118004.
| Device ID | K042026 |
| 510k Number | K042026 |
| Device Name: | BARD CK PARASTOMAL HERNIA PATCH, MODELS 0118001, 0118002, 0118003, 0118004 |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | C.R. BARD, INC. 100 SOCKANOSSETT CROSSROAD Cranston, RI 02920 |
| Contact | Karen S Gwozdowski Gauvin |
| Correspondent | Karen S Gwozdowski Gauvin C.R. BARD, INC. 100 SOCKANOSSETT CROSSROAD 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 | 2004-07-28 |
| Decision Date | 2004-09-10 |
| Summary: | summary |