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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Breast, Powered
510(k) Number K262125
Device Name Nenesupply Venus Handsfree Breast Pump (NBP001-HF)
Applicant
Nenesupply Co., Ltd.
2 F., # 9, Ln. 235, Baoqiao Rd., Xindian District, New Taipe
New Taipei City,  TW 231
Applicant Contact Chia Hui Chiang
Correspondent
Nenesupply Co., Ltd.
2 F., # 9, Ln. 235, Baoqiao Rd., Xindian District, New Taipe
New Taipei City,  TW 231
Correspondent Contact Chia Hui Chiang
Regulation Number884.5160
Classification Product Code
HGX  
Date Received06/24/2026
Decision Date 10/29/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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