MEPILEX
Dressing, Wound And Burn, Occlusive
MOLNLYCKE HEALTH CARE, INC.
The following data is part of a premarket notification filed by Molnlycke Health Care, Inc. with the FDA for Mepilex.
Pre-market Notification Details
| Device ID | K983184 |
| 510k Number | K983184 |
| Device Name: | MEPILEX |
| Classification | Dressing, Wound And Burn, Occlusive |
| Applicant | MOLNLYCKE HEALTH CARE, INC. 500 BALDWIN TOWER Eddystone, PA 19022 |
| Contact | Miguel A Negron |
| Correspondent | Miguel A Negron MOLNLYCKE HEALTH CARE, INC. 500 BALDWIN TOWER Eddystone, PA 19022 |
| Product Code | MGP |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-11 |
| Decision Date | 1998-10-28 |
| Summary: | summary |
Trademark Results [MEPILEX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MEPILEX 77850168 3820862 Live/Registered |
Mölnlycke Health Care AB 2009-10-16 |
 MEPILEX 75582163 2346713 Dead/Cancelled |
Molnlycke Health Care AB 1998-11-03 |
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