The following data is part of a premarket notification filed by Medcare Products with the FDA for Dressing Change Tray.
| Device ID | K841123 |
| 510k Number | K841123 |
| Device Name: | DRESSING CHANGE TRAY |
| Classification | Wrap, Sterilization |
| Applicant | MEDCARE PRODUCTS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FRG |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-03-15 |
| Decision Date | 1984-04-17 |