Agcel Wound Dressing,Agcel Burn Dressing
FDA 510(k) K050842 · Modern Medical Equipment Mfg., Ltd.
510(k) numberK050842
Submission
- Device name
- Agcel Wound Dressing,Agcel Burn Dressing
- Applicant
- Modern Medical Equipment Mfg., Ltd.
Richmond, VA, US - Received
- April 1, 2005
- Decision date
- August 2, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FRO – Dressing, Wound, Drug
- Device class
- Unclassified
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| K254191 | IWD-GelFRO · Traditional | InnovaCorium, Inc. | 04/07/2026SE |
| K252023 | MiraChlor Antimicrobial Wound SolutionFRO · Traditional | Letus Corporation | 03/25/2026SE |
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| K032327 | Modern Medical Bipolar ForcepsGEI · Traditional | 06/15/2004SE |
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Questions and answers
When was Agcel Wound Dressing,Agcel Burn Dressing cleared by the FDA?
Agcel Wound Dressing,Agcel Burn Dressing (K050842) received a 510(k) decision of Substantially Equivalent on August 2, 2006, 488 days after the submission was received.
What is the product code of K050842?
The FDA product code is FRO – Dressing, Wound, Drug, a Unclassified device.