Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP)— 510(k) K241454

Name: FDA 510(k) clearance K241454
Creator: U.S. Food and Drug Administration
Published: 2025-02-03

Substantially Equivalent

Guangzhou Hehong Biotech Co., Ltd.

FDA 510(k) clearance K241454 for Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP), Substantially Equivalent on 2025-02-03. Applicant: Guangzhou Hehong Biotech Co., Ltd.. Device class: 2.

Clearance details

Applicant: Guangzhou Hehong Biotech Co., Ltd.
Product code: Code MQK
Device class: Class 2
Regulation: 21 CFR 884.6160
Advisory panel: Obstetrics/Gynecology
Date received: 2024-05-22
Decision date: 2025-02-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guangzhou, CN

Download summary PDF View on FDA.gov ↗

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