The following data is part of a premarket notification filed by Monlycke Health Care with the FDA for Mepilex Ag Dressing.
| Device ID | K071354 |
| 510k Number | K071354 |
| Device Name: | MEPILEX AG DRESSING |
| Classification | Dressing, Wound, Drug |
| Applicant | MONLYCKE HEALTH CARE 5550 PEACHTREE PKWY. SUITE 500 Norcross, GA 30092 |
| Contact | Steven Dowdley |
| Correspondent | Steven Dowdley MONLYCKE HEALTH CARE 5550 PEACHTREE PKWY. 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 | 2007-05-15 |
| Decision Date | 2007-07-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332551971779 | K071354 | 000 |
| 07332551226954 | K071354 | 000 |
| 07332430612151 | K071354 | 000 |
| 07323190132966 | K071354 | 000 |
| 07332430612076 | K071354 | 000 |
| 07332430612038 | K071354 | 000 |