The following data is part of a premarket notification filed by Unoplast A/s with the FDA for Disarp Original.
| Device ID | K802248 |
| 510k Number | K802248 |
| Device Name: | DISARP ORIGINAL |
| Classification | Suture, Nonabsorbable |
| Applicant | UNOPLAST A/S 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GAO |
| CFR Regulation Number | 878.4495 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-09-16 |
| Decision Date | 1980-09-26 |