Cleared Abbreviated

K060456 - MEDLINE COLLAGEN WOUND DRESSING (FDA 510(k) Clearance)

Jun 2006
Decision
117d
Days
Risk

K060456 is an FDA 510(k) clearance for the MEDLINE COLLAGEN WOUND DRESSING. This device is classified as a Wound Dressing With Animal-derived Material(s).

Submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on June 19, 2006, 117 days after receiving the submission on February 22, 2006.

This device falls under the General & Plastic Surgery FDA review panel.

Submission Details

510(k) Number K060456 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2006
Decision Date June 19, 2006
Days to Decision 117 days
Submission Type Abbreviated
Review Panel General & Plastic Surgery (SU)
Summary Statement

Device Classification

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