The following data is part of a premarket notification filed by Weck with the FDA for Hem-o-lok Xl Clip.
| Device ID | K030311 |
| 510k Number | K030311 |
| Device Name: | HEM-O-LOK XL CLIP |
| Classification | Clip, Implantable |
| Applicant | WECK 2917 WECK DR. Research Triangle Park, NC 27709 |
| Contact | Brian Young |
| Correspondent | Brian Young WECK 2917 WECK DR. Research Triangle Park, NC 27709 |
| Product Code | FZP |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-30 |
| Decision Date | 2003-02-26 |
| Summary: | summary |