K233477

Cryo-straw (Type I, Type III); Warming Kit (A-4ML, B-8ML); Vitrification Kit (A-3ML, B-6ML)

510(k) number
K233477
Device name
Cryo-straw (Type I, Type III); Warming Kit (A-4ML, B-8ML); Vitrification Kit (A-3ML, B-6ML)
Applicant
Shandong Wego Ruisheng Medical Device Co., Ltd. CN
Product code
MQL — Media, Reproductive
Decision date
2024-07-01
Date received
2023-10-26
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain

Also available from FDA: K233477.pdf

Official FDA record: K233477
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.