CHROMOPHARE E 778 AND E 558— 510(k) K083066

Substantially Equivalent

Berchtold Holding GmbH

FDA 510(k) clearance K083066 for CHROMOPHARE E 778 AND E 558, Substantially Equivalent on 2008-10-30. Applicant: Berchtold Holding GmbH.

Clearance details

Applicant: Berchtold Holding GmbH
Product code: Code FSY
Advisory panel: General, Plastic Surgery
Date received: 2008-10-15
Decision date: 2008-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tuttlingen, DE

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Adverse events under product code FSY

product code FSY

Malfunction: 2,759
Other: 1
Total: 2,760

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.