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510(k) K142081

CONTRAST MONITORING SYSTEM DISPLAY, CONTRAST MONITORING SYSTEM SYRINGES by Osprey Medical, Inc. — Product Code DXT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 12, 2014
Date Received
July 31, 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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