Cleared Traditional

K990964 - SIGNADRESS DUODERM DRESSING
(FDA 510(k) Clearance)

K990964 · Convatec, A Division of E.R. Squibb & Sons · General & Plastic Surgery
May 1999
Decision
56d
Days
—
Risk

K990964 is an FDA 510(k) clearance for the SIGNADRESS DUODERM 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 May 18, 1999, 56 days after receiving the submission on March 23, 1999. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number K990964 FDA.gov
FDA Decision Cleared SESE
Date Received March 23, 1999
Decision Date May 18, 1999
Days to Decision 56 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 —