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FDA 510(k), K181330, NeoMatriX Wound Matrix
FDA 510(k), K181330, NeoMatriX Wound Matrix
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510(K) Number: K181330
Device Name: NeoMatriX Wound Matrix
Manufacturer: Jonelle L. Toothman
Device Classification Name: Wound Dressing With Animal-Derived Material(S)
Regulation Number: KGN
Classification Product Code: KXA
Date Received: 05/18/2018
Decision Date: 10/11/2018
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
Device Name: NeoMatriX Wound Matrix
Manufacturer: Jonelle L. Toothman
Device Classification Name: Wound Dressing With Animal-Derived Material(S)
Regulation Number: KGN
Classification Product Code: KXA
Date Received: 05/18/2018
Decision Date: 10/11/2018
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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