The following data is part of a premarket notification filed by Cousin Biotech S.a.r.l with the FDA for Biomesh P1 And Biomesh Plug And Patch.
| Device ID | K002479 |
| 510k Number | K002479 |
| Device Name: | BIOMESH P1 AND BIOMESH PLUG AND PATCH |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | COUSIN BIOTECH S.A.R.L 555 THIRTEENTH STREET, N.W. Washington, DC 20004 -1109 |
| Contact | Howard M Holstein |
| Correspondent | Howard M Holstein COUSIN BIOTECH S.A.R.L 555 THIRTEENTH STREET, N.W. Washington, DC 20004 -1109 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-11 |
| Decision Date | 2000-10-19 |