3M Tegaderm Matrix Dressing
FDA 510(k) K110457 · 3M Company
510(k) numberK110457
Submission
- Device name
- 3M Tegaderm Matrix Dressing
- Applicant
- 3M Company
St. Paul, MN, US - Received
- February 17, 2011
- Decision date
- December 7, 2011
- 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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Questions and answers
When was 3M Tegaderm Matrix Dressing cleared by the FDA?
3M Tegaderm Matrix Dressing (K110457) received a 510(k) decision of Substantially Equivalent on December 7, 2011, 293 days after the submission was received.
What is the product code of K110457?
The FDA product code is FRO – Dressing, Wound, Drug, a Unclassified device.