K965130

Substantially Equivalent

CHROMOPHARE

Applicant: Berchtold Holding GmbH
Product code: FSY
Advisory panel: General, Plastic Surgery
Date received: 1996-12-23
Decision date: 1997-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tuttlingen, DE

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.