The following data is part of a premarket notification filed by Mason-keller Corp. with the FDA for M-k Hydrogel Dressing.
| Device ID | K940409 |
| 510k Number | K940409 |
| Device Name: | M-K HYDROGEL DRESSING |
| Classification | Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
| Applicant | MASON-KELLER CORP. 119 HARRISON AVE. Roseland, NJ 07068 |
| Contact | Al Caggia |
| Correspondent | Al Caggia MASON-KELLER CORP. 119 HARRISON AVE. Roseland, NJ 07068 |
| Product Code | MGQ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-27 |
| Decision Date | 1994-07-11 |