The following data is part of a premarket notification filed by Carapac Systems, Inc. with the FDA for Uni-thane.
| Device ID | K831611 |
| 510k Number | K831611 |
| Device Name: | UNI-THANE |
| Classification | Dressing, Wound, Drug |
| Applicant | CARAPAC SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-05-19 |
| Decision Date | 1983-06-20 |