The following data is part of a premarket notification filed by Cush Medical Products with the FDA for Dressing Change Tray.
| Device ID | K935686 |
| 510k Number | K935686 |
| Device Name: | DRESSING CHANGE TRAY |
| Classification | General Surgery Tray |
| Applicant | CUSH MEDICAL PRODUCTS P.O. BOX 247 881 MOUNTAIN VIEW DRIVE Piney Flats, TN 37686 |
| Contact | Steve B Johnston |
| Correspondent | Steve B Johnston CUSH MEDICAL PRODUCTS P.O. BOX 247 881 MOUNTAIN VIEW DRIVE Piney Flats, TN 37686 |
| Product Code | LRO |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-29 |
| Decision Date | 1994-02-25 |