GEM FLOW COUPLER DEVICE AND SYSTEM
Device Facts
| Record ID | K093310 |
|---|---|
| Device Name | GEM FLOW COUPLER DEVICE AND SYSTEM |
| Applicant | Synovis Micro Companies Alliance, Inc. |
| Product Code | MVR · General, Plastic Surgery |
| Decision Date | Feb 1, 2010 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4300 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.
