The following data is part of a premarket notification filed by Acme United Corp. with the FDA for Op-site Skin Closure Suture Adhesive.
| Device ID | K801884 |
| 510k Number | K801884 |
| Device Name: | OP-SITE SKIN CLOSURE SUTURE ADHESIVE |
| Classification | Strip, Adhesive, Closure, Skin |
| Applicant | ACME UNITED CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FPX |
| CFR Regulation Number | 880.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-08-07 |
| Decision Date | 1980-10-10 |