Burn-Aid Hydrogel,Burn Dressing,Burn Blanket
FDA 510(k) K961067 · Medtrak Intl., Inc.
510(k) numberK961067
Submission
- Device name
- Burn-Aid Hydrogel,Burn Dressing,Burn Blanket
- Applicant
- Medtrak Intl., Inc.
Columbia, MD, US - Received
- March 18, 1996
- Decision date
- May 16, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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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More from Cardiotech Intl.
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| K954506 | EmoxCAW · Traditional | 04/30/1996SE |
Questions and answers
When was Burn-Aid Hydrogel,Burn Dressing,Burn Blanket cleared by the FDA?
Burn-Aid Hydrogel,Burn Dressing,Burn Blanket (K961067) received a 510(k) decision of Substantially Equivalent on May 16, 1996, 59 days after the submission was received.
What is the product code of K961067?
The FDA product code is MGQ – Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic, a Unclassified device.