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510(k) K152978

DeRoyal Angiography Kits by Deroyal Industries, Inc. — Product Code DXT

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
March 25, 2016
Date Received
October 9, 2015
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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