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510(k) K191378

0.9% Sodium Chloride Injection, USP, Pre-filled COP Syringe by Medline Industries, Inc. — Product Code NGT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 2019
Date Received
May 23, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Saline, Vascular Access Flush
Device Class
Class II
Regulation Number
880.5200
Review Panel
HO
Submission Type

Enhance the performance of intravascular catheters, to maintain patency of the vascular catheter when it is not in use.

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