CALPREST— 510(k) K130945

Substantially Equivalent

Eurospital S.P.A.

FDA 510(k) clearance K130945 for CALPREST, Substantially Equivalent on 2014-01-16. Applicant: Eurospital S.P.A.. Device class: 2.

Clearance details

Applicant: Eurospital S.P.A.
Product code: Code NXO
Device class: Class 2
Regulation: 21 CFR 866.5180
Advisory panel: Immunology
Date received: 2013-04-04
Decision date: 2014-01-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Woodstock, GA, US

Download summary PDF View on FDA.gov ↗

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