The following data is part of a premarket notification filed by Weck Closure Systems with the FDA for Hem-o-lock, Model 523935.
| Device ID | K982944 |
| 510k Number | K982944 |
| Device Name: | HEM-O-LOCK, MODEL 523935 |
| Classification | Clip, Implantable |
| Applicant | WECK CLOSURE SYSTEMS ONE WECK DR. Research Triangle Park, NC 27709 |
| Contact | Brian J Young |
| Correspondent | Brian J 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 | 1998-08-21 |
| Decision Date | 1998-11-19 |
| Summary: | summary |