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

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..

Clearance details

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

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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.