The following data is part of a premarket notification filed by American Cyanamid Co. with the FDA for Appose Skin Stapler & Remover.
| Device ID | K823552 |
| 510k Number | K823552 |
| Device Name: | APPOSE SKIN STAPLER & REMOVER |
| Classification | Staple, Implantable |
| Applicant | AMERICAN CYANAMID CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-11-30 |
| Decision Date | 1983-06-15 |