The following data is part of a premarket notification filed by Weck with the FDA for Weck Hem-o-lok Automatic Ligating Clip Applier.
| Device ID | K021808 |
| 510k Number | K021808 |
| Device Name: | WECK HEM-O-LOK AUTOMATIC LIGATING CLIP APPLIER |
| Classification | Clip, Implantable |
| Applicant | WECK 2917 WECK DR. Durham, NC 27709 |
| Contact | James Lucky |
| Correspondent | James Lucky WECK 2917 WECK DR. Durham, 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 | 2002-06-03 |
| Decision Date | 2002-08-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 54026704625173 | K021808 | 000 |