DeviceClearance

Cellusheet, Cellufil— 510(k) K213092

Substantially Equivalent

Human Biosciences, Inc.

FDA 510(k) clearance K213092 for Cellusheet, Cellufil, Substantially Equivalent on 2021-12-15. Applicant: Human Biosciences, Inc.. Device class: Unclassified.

Clearance details

Applicant
Human Biosciences, Inc.
Product code
Code KGN
Device class
Unclassified
Advisory panel
Unknown
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Gaithersburg, MD, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code KGN

product code KGN
Other
2
Total
2

Source: openFDA MAUDE database, through . 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.