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510(k) K162088

Ecomed Disposable Angiographic Syringes by Ecomed Solutions, LLC — Product Code DXT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 2017
Date Received
July 28, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Injector And Syringe, Angiographic
Device Class
Class II
Regulation Number
870.1650
Review Panel
HO
Submission Type

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