HEM-O-LOK SMX, MODEL 544220; HEM-O-LOK ML, MODEL 544230; HEM-O-LOK MLX, MODEL 544240
Device Facts
| Record ID | K003337 |
|---|---|
| Device Name | HEM-O-LOK SMX, MODEL 544220; HEM-O-LOK ML, MODEL 544230; HEM-O-LOK MLX, MODEL 544240 |
| Applicant | Weck Closure Systems |
| Product Code | FZP · General, Plastic Surgery |
| Decision Date | Dec 21, 2000 |
| 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.
