The following data is part of a premarket notification filed by Temp-stik Corp. with the FDA for Surgical Products, Skin Staple Remover.
| Device ID | K822963 |
| 510k Number | K822963 |
| Device Name: | SURGICAL PRODUCTS, SKIN STAPLE REMOVER |
| Classification | Clip, Removable (skin) |
| Applicant | TEMP-STIK 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 | 1982-10-05 |
| Decision Date | 1982-11-08 |