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510(k) K173665

AMSafe Sure-Lok Needle-Free Connector by Amsino International, Inc. — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 5, 2018
Date Received
November 29, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, Intravascular
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

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  • K171857 — AMSure® Enteral Feeding Syringe with ENFit Tip (March 30, 2018)
  • K101958 — AMSINO I.V. ADMINISTRATION AND EXTENSION SETS (September 29, 2010)

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