The following data is part of a premarket notification filed by Medtrax Industries, Inc. with the FDA for Wet Dressing.
Device ID | K940691 |
510k Number | K940691 |
Device Name: | WET DRESSING |
Classification | Dressing, Wound And Burn, Occlusive |
Applicant | MEDTRAX INDUSTRIES, INC. 1372 BENNETT DR. SUITE 156 Longwood, FL 32750 |
Contact | Juan Alana |
Correspondent | Juan Alana MEDTRAX INDUSTRIES, INC. 1372 BENNETT DR. SUITE 156 Longwood, FL 32750 |
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 | 1994-02-16 |
Decision Date | 1994-03-31 |