The following data is part of a premarket notification filed by Medikmark, Inc. with the FDA for Dressing Change Tray.
| Device ID | K920339 |
| 510k Number | K920339 |
| Device Name: | DRESSING CHANGE TRAY |
| Classification | Wrap, Sterilization |
| Applicant | MEDIKMARK, INC. 333 WEST WACKER DR. SUITE 2600 Chicago, IL 60606 |
| Contact | Richard O Wood |
| Correspondent | Richard O Wood MEDIKMARK, INC. 333 WEST WACKER DR. SUITE 2600 Chicago, IL 60606 |
| Product Code | FRG |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-01-24 |
| Decision Date | 1992-04-23 |