The following data is part of a premarket notification filed by Molnlycke Health Care with the FDA for Mepilex Ag Absorbent Silicone-coated Dressing.
| Device ID | K061554 |
| 510k Number | K061554 |
| Device Name: | MEPILEX AG ABSORBENT SILICONE-COATED DRESSING |
| Classification | Dressing, Wound, Drug |
| Applicant | MOLNLYCKE HEALTH CARE 5550 PEACHTREE PARKWAY SUITE 500 Norcross, GA 30092 |
| Contact | Steven Dowdley |
| Correspondent | Steven Dowdley 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 | 2006-06-05 |
| Decision Date | 2007-01-25 |
| Summary: | summary |