The following data is part of a premarket notification filed by Acme United Corp. with the FDA for One Time Disposable Skin Stapler.
| Device ID | K830704 |
| 510k Number | K830704 |
| Device Name: | ONE TIME DISPOSABLE SKIN STAPLER |
| Classification | Clip, Removable (skin) |
| Applicant | ACME UNITED CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FZQ |
| CFR Regulation Number | 878.4320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-03-07 |
| Decision Date | 1983-04-12 |