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510(k) K171698

Smart Syringe by Osprey Medical, Inc. — Product Code DXT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 7, 2017
Date Received
June 8, 2017
Clearance Type
Special
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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