ICSI-100— 510(k) K043116

Substantially Equivalent

Vitrolife Sweden AB

FDA 510(k) clearance K043116 for ICSI-100, Substantially Equivalent on 2005-01-13. Applicant: Vitrolife Sweden AB.

Clearance details

Applicant: Vitrolife Sweden AB
Product code: Code MQL
Advisory panel: Obstetrics/Gynecology
Date received: 2004-11-10
Decision date: 2005-01-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kungsbacka, SE

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