The following data is part of a premarket notification filed by Maersk Medical, Ltd. with the FDA for Arglaes-ab Antimicrobial Barrier Powder Dressing.
| Device ID | K004028 |
| 510k Number | K004028 |
| Device Name: | ARGLAES-AB ANTIMICROBIAL BARRIER POWDER DRESSING |
| Classification | Dressing, Wound And Burn, Occlusive |
| Applicant | MAERSK MEDICAL, LTD. ONE MEDLINE PLACE Mundelein, IL 60060 |
| Contact | Lara N Simmons |
| Correspondent | Lara N Simmons MAERSK MEDICAL, LTD. ONE MEDLINE PLACE Mundelein, IL 60060 |
| Product Code | MGP |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-27 |
| Decision Date | 2001-03-27 |