OIL FOR TISSUE CULTURE, GRADIENT SYSTEM AND SPERMFREEZE— 510(k) K053494

Name: FDA 510(k) clearance K053494
Creator: U.S. Food and Drug Administration
Published: 2006-03-23

Substantially Equivalent

Fertipro NV

FDA 510(k) clearance K053494 for OIL FOR TISSUE CULTURE, GRADIENT SYSTEM AND SPERMFREEZE, Substantially Equivalent on 2006-03-23. Applicant: Fertipro NV. Device class: 2.

Clearance details

Applicant: Fertipro NV
Product code: Code MQL
Device class: Class 2
Regulation: 21 CFR 884.6180
Advisory panel: Obstetrics/Gynecology
Date received: 2005-12-15
Decision date: 2006-03-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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