TUMARK PROFESSIONAL, MODEL 271560; MR- TUMARK PROFESSIONAL, MODEL 601560— 510(k) K073095

Substantially Equivalent

Somatex Medical Technologies GmbH

FDA 510(k) clearance K073095 for TUMARK PROFESSIONAL, MODEL 271560; MR- TUMARK PROFESSIONAL, MODEL 601560, Substantially Equivalent on 2008-03-19. Applicant: Somatex Medical Technologies GmbH.

Clearance details

Applicant: Somatex Medical Technologies GmbH
Product code: Code NEU
Advisory panel: General, Plastic Surgery
Date received: 2007-11-01
Decision date: 2008-03-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cambridge, MA, US

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Adverse events under product code NEU

product code NEU

Injury: 824
Total: 824

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.