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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 K251512
Device Name Hi bebe super (BT-150B)
Applicant
Bistos Co., Ltd.
7th Floor , A Bldg., Woolim Lions Valley 5-Cha, 302
Galmachi-Ro, Jungwon-Gu
Seongnam-Si,  KR 13201
Applicant Contact HYE JEONG KIM
Correspondent
Bistos Co., Ltd.
7th Floor , A Bldg., Woolim Lions Valley 5-Cha, 302
Galmachi-Ro, Jungwon-Gu
Seongnam-Si,  KR 13201
Correspondent Contact HYE JEONG KIM
Regulation Number884.5160
Classification Product Code
HGX  
Date Received05/16/2025
Decision Date 09/25/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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