DeviceClearance

CHROMOPHARE E 668— 510(k) K090378

Substantially Equivalent

Berchtold GmbH & Co. KG

FDA 510(k) clearance K090378 for CHROMOPHARE E 668, Substantially Equivalent on 2009-02-23. Applicant: Berchtold GmbH & Co. KG.

Clearance details

Applicant
Berchtold GmbH & Co. KG
Product code
Code FSY
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Charleston, SC, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code FSY

product code FSY
Malfunction
2,759
Other
1
Total
2,760

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.