FOAM CALCIUM ALGINATE TOPICAL WOUND DRESSING WITH COLLAGEN— 510(k) K000054

Substantially Equivalent

Adri

FDA 510(k) clearance K000054 for FOAM CALCIUM ALGINATE TOPICAL WOUND DRESSING WITH COLLAGEN, Substantially Equivalent on 2000-03-13. Applicant: Adri.

Clearance details

Applicant: Adri
Product code: Code KGN
Advisory panel: Unknown
Date received: 2000-01-07
Decision date: 2000-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Park Forest, IL, US

Download summary PDF View on FDA.gov ↗

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.