BIOSIL MEDICAL GRADE SILICONE SHEETING FOR OBSTETRICAL & GYNOCOLOGY APPLICATIONS
Device Facts
| Record ID | K933827 |
|---|---|
| Device Name | BIOSIL MEDICAL GRADE SILICONE SHEETING FOR OBSTETRICAL & GYNOCOLOGY APPLICATIONS |
| Applicant | Bioplexus Corp. |
| Product Code | FTL · General, Plastic Surgery |
| Decision Date | Jun 30, 1994 |
| 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.
