SIC 8000— 510(k) K150852

Substantially Equivalent

Cosmo Technologies, Ltd.

FDA 510(k) clearance K150852 for SIC 8000, Substantially Equivalent on 2015-09-03. Applicant: Cosmo Technologies, Ltd.. Device class: 2.

Clearance details

Applicant: Cosmo Technologies, Ltd.
Product code: Code PLL
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2015-03-31
Decision date: 2015-09-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dublin 1, IE

Download summary PDF View on FDA.gov ↗

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