Cleared Traditional

KENDALL HYDROPHILIC POWDER WOUND DRESSING

K970266 · Kendall Healthcare Products Co. Div.Of Tyco Health · General & Plastic Surgery
Apr 1997
Decision
90d
Days
—
Risk

About This 510(k) Submission

K970266 is an FDA 510(k) clearance for the KENDALL HYDROPHILIC POWDER WOUND DRESSING, a Wound Dressing With Animal-derived Material(s), submitted by Kendall Healthcare Products Co. Div.Of Tyco Health (Mansfield, US). The FDA issued a Cleared decision on April 23, 1997, 90 days after receiving the submission on January 23, 1997. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number K970266 FDA.gov
FDA Decision Cleared SN
Date Received January 23, 1997
Decision Date April 23, 1997
Days to Decision 90 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

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