DeviceClearance

MatriDerm— 510(k) K201577

Substantially Equivalent

Medskin Solutions Dr. Suwelack AG

FDA 510(k) clearance K201577 for MatriDerm, Substantially Equivalent on 2021-01-07. Applicant: Medskin Solutions Dr. Suwelack AG. Device class: Unclassified.

Clearance details

Applicant
Medskin Solutions Dr. Suwelack AG
Product code
Code KGN
Device class
Unclassified
Advisory panel
Unknown
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Billerbeck, DE
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.