Cleared Traditional

K984388 - HA ABSORBENT WOUND DRESSING
(FDA 510(k) Clearance)

K984388 · Convatec, A Division of E.R. Squibb & Sons · General & Plastic Surgery
Mar 1999
Decision
85d
Days
Risk

K984388 is an FDA 510(k) clearance for the HA ABSORBENT WOUND DRESSING, a Wound Dressing With Animal-derived Material(s), submitted by Convatec, A Division of E.R. Squibb & Sons (Skillman, US). The FDA issued a Cleared decision on March 3, 1999, 85 days after receiving the submission on December 8, 1998. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number K984388 FDA.gov
FDA Decision Cleared SESE
Date Received December 08, 1998
Decision Date March 03, 1999
Days to Decision 85 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