The following data is part of a premarket notification filed by Molnlycke Health Care with the FDA for Mepilex Border Ag Dressing.
| Device ID | K100029 |
| 510k Number | K100029 |
| Device Name: | MEPILEX BORDER AG 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 | Yes |
| Date Received | 2010-01-06 |
| Decision Date | 2010-09-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332551895181 | K100029 | 000 |
| 07323190142460 | K100029 | 000 |
| 07323190142507 | K100029 | 000 |
| 07323190142545 | K100029 | 000 |
| 07323190142583 | K100029 | 000 |
| 07332551822910 | K100029 | 000 |
| 07332551822996 | K100029 | 000 |
| 07332551823030 | K100029 | 000 |
| 07332551823061 | K100029 | 000 |
| 07332551894931 | K100029 | 000 |
| 07332551894986 | K100029 | 000 |
| 07332551895037 | K100029 | 000 |
| 07332551895075 | K100029 | 000 |
| 07323190142422 | K100029 | 000 |