Burn-Aid Hydrogel, Burn-Aid Burn Dressing, Burn-Aid Burn Blanket
FDA 510(k) K984082 · Emox 911 CC
510(k) numberK984082
Submission
- Device name
- Burn-Aid Hydrogel, Burn-Aid Burn Dressing, Burn-Aid Burn Blanket
- Applicant
- Emox 911 CC
Somerset West, ZA - Received
- November 16, 1998
- Decision date
- January 28, 1999
- 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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| K083024 | Hylatopic Emollient FoamMGQ · Traditional | Collegium Pharmaceutical Incorporated | 03/27/2009SE |
| K041342 | Impruv A.I. Cream Wound and Skin EmulsionMGQ · Traditional | Stiefel Laboratories, Inc. | 07/19/2005SE |
| K041268 | Silversite or CalgitrolMGQ · Traditional | Adri | 09/20/2004SE |
| K040019 | SilversealMGQ · Traditional | Noble Fiber Technologies | 07/23/2004SE |
| K040517 | Tenderwet ActiveMGQ · Traditional | Medline Industries, Inc. | 03/25/2004SE |
| K022587 | Medtrade Product's Antiseptic Barrier Hydrogel DressingsMGQ · Traditional | Medtrade Products , Ltd. | 08/22/2003SE |
| K024367 | Sinclair Wound and Skin EmulsionMGQ · Traditional | Sinclair Pharmaceuticals, Ltd. | 07/28/2003SE |
| K024054 | Xylos Xcell Antimicrobial DressingMGQ · Traditional | Xylos Corporation | 03/07/2003SE |
| K022584 | Cardiotech Antibotic Hydrogel Wound DressingMGQ · Traditional | Cardiotech Intl. | 12/30/2002SE |
More from Cardiotech Intl.
| 510(k) | Device | Decision |
|---|---|---|
| K984081 | EmoxCAW · Traditional | 03/17/1999SE |
Questions and answers
When was Burn-Aid Hydrogel, Burn-Aid Burn Dressing, Burn-Aid Burn Blanket cleared by the FDA?
Burn-Aid Hydrogel, Burn-Aid Burn Dressing, Burn-Aid Burn Blanket (K984082) received a 510(k) decision of Substantially Equivalent on January 28, 1999, 73 days after the submission was received.
What is the product code of K984082?
The FDA product code is MGQ – Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic, a Unclassified device.