The following data is part of a premarket notification filed by Maersk Medical, Ltd. with the FDA for Arglaes Film Dressing.
| Device ID | K970566 |
| 510k Number | K970566 |
| Device Name: | ARGLAES FILM DRESSING |
| Classification | Dressing, Wound And Burn, Occlusive |
| Applicant | MAERSK MEDICAL, LTD. THORNHILL RD., NORTH MOONS MOAT Redditch, Worcestershire, GB B98 9nl |
| Contact | David Mitchell |
| Correspondent | David Mitchell MAERSK MEDICAL, LTD. THORNHILL RD., NORTH MOONS MOAT Redditch, Worcestershire, GB B98 9nl |
| 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 | 1997-02-13 |
| Decision Date | 1997-07-29 |