The following data is part of a premarket notification filed by Sterile Design, Inc. with the FDA for Custom Dressing Change Trays.
| Device ID | K791738 |
| 510k Number | K791738 |
| Device Name: | CUSTOM DRESSING CHANGE TRAYS |
| Classification | Patient Examination Glove |
| Applicant | STERILE DESIGN, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FMC |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-08-30 |
| Decision Date | 1979-10-02 |