The following data is part of a premarket notification filed by Davol, Inc. with the FDA for Composix Kugel Mesh, Model 0010201,0010202,0010203,0010204,0010205.
| Device ID | K003323 |
| 510k Number | K003323 |
| Device Name: | COMPOSIX KUGEL MESH, MODEL 0010201,0010202,0010203,0010204,0010205 |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | DAVOL, INC. SUBSIDIARY OF C.R. BARD 100 SOCKANOSSETT CROSSROAD Cranston, RI 02920 |
| Contact | Paula E Bulger |
| Correspondent | Paula E Bulger DAVOL, INC. SUBSIDIARY OF C.R. BARD 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 | 2000-10-24 |
| Decision Date | 2001-01-22 |