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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K252543
Device Name AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)
Applicant
Amsino International, Inc.
708 Corporate Center Dr.
Pomona,  CA  91768
Applicant Contact Jane Gao
Correspondent
Amsino International, Inc.
708 Corporate Center Dr.
Pomona,  CA  91768
Correspondent Contact Jane Gao
Regulation Number880.5440
Classification Product Code
FPA  
Date Received08/12/2025
Decision Date 05/04/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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