The following data is part of a premarket notification filed by Molnlycke Health Care, Us Llc with the FDA for Exufiber Ag+.
| Device ID | K160379 |
| 510k Number | K160379 |
| Device Name: | Exufiber Ag+ |
| Classification | Dressing, Wound, Drug |
| Applicant | MOLNLYCKE HEALTH CARE, US LLC 5550 PEACHTREE PARKWAY, SUITE 500 Norcross, GA 30092 |
| Contact | Megan Bevill |
| Correspondent | Megan Bevill MOLNLYCKE HEALTH CARE, US LLC 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 | 2016-02-10 |
| Decision Date | 2016-08-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07323190152759 | K160379 | 000 |
| 07323190152483 | K160379 | 000 |
| 07323190152599 | K160379 | 000 |
| 07323190152711 | K160379 | 000 |
| 07323190152568 | K160379 | 000 |
| 07323190152681 | K160379 | 000 |