The following data is part of a premarket notification filed by Edward Weck, Inc. with the FDA for Skin Staple Remover #523770.
| Device ID | K801444 |
| 510k Number | K801444 |
| Device Name: | SKIN STAPLE REMOVER #523770 |
| Classification | Staple, Removable (skin) |
| Applicant | EDWARD WECK, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GDT |
| CFR Regulation Number | 878.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-06-20 |
| Decision Date | 1980-07-14 |