The following data is part of a premarket notification filed by Weck Closure Systems with the FDA for Hem-o-lok Smx Polymer Clips, Model 544220, Hem-0-lok Mlx Polymer Clips, Model 544240.
| Device ID | K993157 |
| 510k Number | K993157 |
| Device Name: | HEM-O-LOK SMX POLYMER CLIPS, MODEL 544220, HEM-0-LOK MLX POLYMER CLIPS, MODEL 544240 |
| Classification | Clip, Implantable |
| Applicant | WECK CLOSURE SYSTEMS ONE WECK DR. Research Triangle Park, NC 27709 |
| Contact | Brian Young |
| Correspondent | Brian Young WECK CLOSURE SYSTEMS ONE 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 | 1999-09-21 |
| Decision Date | 1999-12-17 |
| Summary: | summary |