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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 K173665
Device Name AMSafe Sure-Lok Needle-Free Connector
Applicant
Amsino International, Inc.
708 Corporate Center Drive
Pomona,  CA  91768
Applicant Contact Cathy Hong
Correspondent
Amsino International, Inc.
708 Corporate Center Drive
Pomona,  CA  91768
Correspondent Contact Cathy Hong
Regulation Number880.5440
Classification Product Code
FPA  
Date Received11/29/2017
Decision Date 09/05/2018
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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