BIOMESH P1 AND BIOMESH PLUG AND PATCH
Device Facts
| Record ID | K002479 |
|---|---|
| Device Name | BIOMESH P1 AND BIOMESH PLUG AND PATCH |
| Applicant | Cousin Biotech S.A.R.L |
| Product Code | FTL · General, Plastic Surgery |
| Decision Date | Oct 19, 2000 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.3300 |
| Device Class | Class 2 |
Regulatory Classification
Identification
Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.
