The following data is part of a premarket notification filed by Medsurg Industries, Inc. with the FDA for Dressing Change Tray-modified.
| Device ID | K931932 |
| 510k Number | K931932 |
| Device Name: | DRESSING CHANGE TRAY-MODIFIED |
| Classification | Wound Dressing Kit |
| Applicant | MEDSURG INDUSTRIES, INC. 251 EXCHANGE PLACE Herndon, VA 20170 -4822 |
| Contact | Thomas B Bonner |
| Correspondent | Thomas B Bonner MEDSURG INDUSTRIES, INC. 251 EXCHANGE PLACE Herndon, VA 20170 -4822 |
| Product Code | MCY |
| CFR Regulation Number | 880.5075 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-19 |
| Decision Date | 1993-08-27 |