The following data is part of a premarket notification filed by Weck Closure Systems with the FDA for Hem-o-lok Smx, Model 544220; Hem-o-lok Ml, Model 544230; Hem-o-lok Mlx, Model 544240.
| Device ID | K003337 |
| 510k Number | K003337 |
| Device Name: | HEM-O-LOK SMX, MODEL 544220; HEM-O-LOK ML, MODEL 544230; HEM-O-LOK MLX, MODEL 544240 |
| Classification | Clip, Implantable |
| Applicant | WECK CLOSURE SYSTEMS 1 WECK DR. Research Triangle Park, NC 27709 |
| Contact | Brian Young |
| Correspondent | Brian Young WECK CLOSURE SYSTEMS 1 WECK DR. Research Triangle Park, NC 27709 |
| Product Code | FZP |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-25 |
| Decision Date | 2000-12-21 |