CHROMOPHARE F 628 AND F 528— 510(k) K120392

Substantially Equivalent

Berchtold GmbH & Co. KG

FDA 510(k) clearance K120392 for CHROMOPHARE F 628 AND F 528, Substantially Equivalent on 2012-02-16. Applicant: Berchtold GmbH & Co. KG.

Clearance details

Applicant: Berchtold GmbH & Co. KG
Product code: Code FSY
Advisory panel: General, Plastic Surgery
Date received: 2012-02-08
Decision date: 2012-02-16
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.