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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 K183473
Device Name AMSafe(R) Pre-Filled Normal Saline Flush Syringe
Applicant
Amsino International, Inc.
708 Corporate Center Dr.
Pomona,  CA  91768
Applicant Contact Jim Barley
Correspondent
Amsino International, Inc.
708 Corporate Center Dr.
Pomona,  CA  91768
Correspondent Contact Jim Barley
Regulation Number880.5200
Classification Product Code
NGT  
Date Received12/14/2018
Decision Date 07/12/2019
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
Predetermined Change
Control Plan Authorized		 No
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