The following data is part of a premarket notification filed by Molnlycke Health Care with the FDA for Mepilex Transfer Ag.
| Device ID | K123892 |
| 510k Number | K123892 |
| Device Name: | MEPILEX TRANSFER AG |
| Classification | Dressing, Wound, Drug |
| Applicant | MOLNLYCKE HEALTH CARE 5550 PEACHTREE PARKWAY SUITE 500 Norcross, GA 30092 |
| Contact | Angela L Bunn, Rac |
| Correspondent | Angela L Bunn, Rac MOLNLYCKE HEALTH CARE 5550 PEACHTREE PARKWAY SUITE 500 Norcross, GA 30092 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-18 |
| Decision Date | 2013-04-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07323190013395 | K123892 | 000 |
| 07323190013531 | K123892 | 000 |
| 07323190013203 | K123892 | 000 |