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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Assisted Reproduction
510(k) Number K253354
Device Name Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175-C, ETCB20175-ET, ETCB20175-ET-C)
Applicant
Guangzhou Hehong Biotech Co., Ltd.
A Zone, 2/F, Bldg. A, Huazi Industrial Park,
Shilou Town, Panyu District
Guangzhou,  CN 511447
Applicant Contact Yu Feng
Correspondent
Guangzhou Hehong Biotech Co., Ltd.
A Zone, 2/F, Bldg. A, Huazi Industrial Park,
Shilou Town, Panyu District
Guangzhou,  CN 511447
Correspondent Contact Lena Liang
Regulation Number884.6110
Classification Product Code
MQF  
Date Received09/30/2025
Decision Date 02/12/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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