The following data is part of a premarket notification filed by Mason-keller Corp. with the FDA for M-k Wet Saline Dressing.
Device ID | K940110 |
510k Number | K940110 |
Device Name: | M-K WET SALINE DRESSING |
Classification | Dressing, Wound And Burn, Occlusive |
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 | MGP |
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 | 1994-01-10 |
Decision Date | 1994-03-22 |