HELIDERM COLLAGEN WOUND DRESSINGS 0.5 GRAM AND 1.0 GRAM— 510(k) K990086

Name: FDA 510(k) clearance K990086
Creator: U.S. Food and Drug Administration
Published: 1999-03-31

Substantially Equivalent

Integra Lifesciences Corp.

FDA 510(k) clearance K990086 for HELIDERM COLLAGEN WOUND DRESSINGS 0.5 GRAM AND 1.0 GRAM, Substantially Equivalent on 1999-03-31. Applicant: Integra Lifesciences Corp.. Device class: Unclassified.

Clearance details

Applicant: Integra Lifesciences Corp.
Product code: Code KGN
Device class: Unclassified
Advisory panel: Unknown
Date received: 1999-01-11
Decision date: 1999-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plainsboro, NJ, US

Download summary PDF View on FDA.gov ↗

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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.