The following data is part of a premarket notification filed by Molnlycke Health Care with the FDA for Mepitel Ag.
| Device ID | K130040 |
| 510k Number | K130040 |
| Device Name: | MEPITEL AG |
| Classification | Dressing, Wound, Drug |
| Applicant | MOLNLYCKE HEALTH CARE 5550 PEACHTREE PARKWAY SUITE 500 Norcross, GA 30092 |
| Contact | Angela L Bunn |
| Correspondent | Angela L Bunn 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 | Yes |
| Date Received | 2013-01-07 |
| Decision Date | 2014-02-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07323190019816 | K130040 | 000 |
| 07323190019762 | K130040 | 000 |
| 07323190019731 | K130040 | 000 |
| 07323190019687 | K130040 | 000 |
| 07323190019656 | K130040 | 000 |
| 07323190019618 | K130040 | 000 |