SIGNADRESS DUODERM DRESSING— 510(k) K990964

Name: FDA 510(k) clearance K990964
Creator: U.S. Food and Drug Administration
Published: 1999-05-18

Substantially Equivalent

Convatec, A Division of E.R. Squibb & Sons

FDA 510(k) clearance K990964 for SIGNADRESS DUODERM DRESSING, Substantially Equivalent on 1999-05-18. Applicant: Convatec, A Division of E.R. Squibb & Sons. Device class: Unclassified.

Clearance details

Applicant: Convatec, A Division of E.R. Squibb & Sons
Product code: Product code KGN
Device class: Unclassified
Advisory panel: Unknown
Date received: 1999-03-23
Decision date: 1999-05-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Skillman, NJ, US

Download summary PDF View on FDA.gov ↗

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K980720 — NONWOVEN PAD1998-04-15
K980382 — NON-WOVEN COMPRESS1998-03-09
K974823 — NONWOVEN DRESSING1998-02-20

Adverse events under product code KGN

product code KGN

Other: 2
Total: 2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.