The following data is part of a premarket notification filed by Mason-keller Corp. with the FDA for Dressing Change Kit.
| Device ID | K940069 |
| 510k Number | K940069 |
| Device Name: | DRESSING CHANGE KIT |
| Classification | Gown, Surgical |
| Applicant | MASON-KELLER CORP. 119 HARRISON AVE. Roseland, NJ 07068 |
| Contact | Alfred R Caggia |
| Correspondent | Alfred R Caggia MASON-KELLER CORP. 119 HARRISON AVE. Roseland, NJ 07068 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-06 |
| Decision Date | 1994-03-18 |