CALCULI FILTER CUP— 510(k) K820180

Substantially Equivalent

Omnimedical

FDA 510(k) clearance K820180 for CALCULI FILTER CUP, Substantially Equivalent on 1982-02-05. Applicant: Omnimedical. Device class: 1.

Clearance details

Applicant: Omnimedical
Product code: Code FMH
Device class: Class 1
Regulation: 21 CFR 864.3250
Advisory panel: Pathology
Date received: 1982-01-22
Decision date: 1982-02-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Data sourced from openFDA. This site is unofficial and independent of the FDA.