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510(k) K140425

CONTRAST MODULATION SYSTEM by Osprey Medical, Inc. — Product Code DXT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 2014
Date Received
February 19, 2014
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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  • K151300 — AVERT Contrast Modulation System (October 15, 2015)
  • K151746 — Dyevert Contrast Modulation System (October 9, 2015)

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