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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name saline, vascular access flush
510(k) Number K213522
Device Name AMSafe Pre-Filled Normal Saline Flush Syringe
Applicant
Amsino International, Inc.
708 Corporate Center Drive
Pomona,  CA  91768
Applicant Contact Jane Gao
Correspondent
Amsino International, Inc.
708 Corporate Center Drive
Pomona,  CA  91768
Correspondent Contact Jane Gao
Regulation Number880.5200
Classification Product Code
NGT  
Date Received11/03/2021
Decision Date 03/22/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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