Cleared Traditional

COLACTIVE COLLAGEN WOUND DRESSING

K050177 · Covalontechnologies, Inc. · General & Plastic Surgery
Apr 2005
Decision
91d
Days
Risk

About This 510(k) Submission

K050177 is an FDA 510(k) clearance for the COLACTIVE COLLAGEN WOUND DRESSING, a Wound Dressing With Animal-derived Material(s), submitted by Covalontechnologies, Inc. (Largo, US). The FDA issued a Cleared decision on April 27, 2005, 91 days after receiving the submission on January 26, 2005. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number K050177 FDA.gov
FDA Decision Cleared SESE
Date Received January 26, 2005
Decision Date April 27, 2005
Days to Decision 91 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