Ambu Gel, Hydrogel Burn Dressing
FDA 510(k) K010583 · Ambu, Inc.
510(k) numberK010583
Submission
- Device name
- Ambu Gel, Hydrogel Burn Dressing
- Applicant
- Ambu, Inc.
Linthicum, MD, US - Received
- February 27, 2001
- Decision date
- May 25, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- MGQ – Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
- Device class
- Unclassified
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Questions and answers
When was Ambu Gel, Hydrogel Burn Dressing cleared by the FDA?
Ambu Gel, Hydrogel Burn Dressing (K010583) received a 510(k) decision of Substantially Equivalent on May 25, 2001, 87 days after the submission was received.
What is the product code of K010583?
The FDA product code is MGQ – Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic, a Unclassified device.