Cleared Special

MATRISTEM WOUND MATRIX

K112409 · Acell, Inc. · General & Plastic Surgery
Aug 2011
Decision
7d
Days
—
Risk

About This 510(k) Submission

K112409 is an FDA 510(k) clearance for the MATRISTEM WOUND MATRIX, a Wound Dressing With Animal-derived Material(s), submitted by Acell, Inc. (Columbia, US). The FDA issued a Cleared decision on August 29, 2011, 7 days after receiving the submission on August 22, 2011. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number K112409 FDA.gov
FDA Decision Cleared SESE
Date Received August 22, 2011
Decision Date August 29, 2011
Days to Decision 7 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code KGN — Wound Dressing With Animal-derived Material(s)
Device Class —