The following data is part of a premarket notification filed by Ambu, Inc. with the FDA for Ambu Gel, Hydrogel Burn Dressing.
| Device ID | K010583 |
| 510k Number | K010583 |
| Device Name: | AMBU GEL, HYDROGEL BURN DRESSING |
| Classification | Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
| Applicant | AMBU, INC. 611 NORTH HAMMONDS FERRY RD. Linthicum, MD 21090 -1356 |
| Contact | Sanjay Parikh |
| Correspondent | Sanjay Parikh AMBU, INC. 611 NORTH HAMMONDS FERRY RD. Linthicum, MD 21090 -1356 |
| Product Code | MGQ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-02-27 |
| Decision Date | 2001-05-25 |