The following data is part of a premarket notification filed by Maersk Medical, Ltd. with the FDA for Arglaes-ab Antimicrobial Barrier Island Dressing.
| Device ID | K973657 |
| 510k Number | K973657 |
| Device Name: | ARGLAES-AB ANTIMICROBIAL BARRIER ISLAND DRESSING |
| Classification | Dressing, Wound And Burn, Occlusive |
| Applicant | MAERSK MEDICAL, LTD. 7527 WESTMORELAND AVE. St. Louis, MO 63105 |
| Contact | Evan Dick |
| Correspondent | Evan Dick MAERSK MEDICAL, LTD. 7527 WESTMORELAND AVE. St. Louis, MO 63105 |
| Product Code | MGP |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-25 |
| Decision Date | 1997-12-01 |