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510(k) K241454

Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP) by Guangzhou Hehong Biotech Co., Ltd. — Product Code MQK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 3, 2025
Date Received
May 22, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Labware, Assisted Reproduction
Device Class
Class II
Regulation Number
884.6160
Review Panel
OB
Submission Type

Other clearances by Guangzhou Hehong Biotech Co., Ltd.

  • K253354 — Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175 (February 12, 2026)

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