SKINTEMP, MODIFICATION— 510(k) K925545

Substantially Equivalent

Biocore

FDA 510(k) clearance K925545 for SKINTEMP, MODIFICATION, Substantially Equivalent on 1993-02-23. Applicant: Biocore.

Clearance details

Applicant: Biocore
Product code: Code KGN
Advisory panel: Unknown
Date received: 1992-10-15
Decision date: 1993-02-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Topeka, KS, US

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Adverse events under product code KGN

product code KGN

Other: 2
Total: 2

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.