Cleared Traditional

BILAYER MATRIX WOUND DRESSING

K021792 · Integra Lifesciences Corp. · General & Plastic Surgery
Aug 2002
Decision
75d
Days
—
Risk

About This 510(k) Submission

K021792 is an FDA 510(k) clearance for the BILAYER MATRIX WOUND DRESSING, a Wound Dressing With Animal-derived Material(s), submitted by Integra Lifesciences Corp. (Planisboro, US). The FDA issued a Cleared decision on August 14, 2002, 75 days after receiving the submission on May 31, 2002. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number K021792 FDA.gov
FDA Decision Cleared SESE
Date Received May 31, 2002
Decision Date August 14, 2002
Days to Decision 75 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

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