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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Injector And Syringe, Angiographic
510(k) Number K153141
Device Name DyeVert Contrast Modulation System
Applicant
Osprey Medical, Inc.
5600 Rowland Rd. Suite 250
Minnetonka,  MN  55343
Applicant Contact MELANIE HESS
Correspondent
Osprey Medical, Inc.
5600 Rowland Rd. Suite 250
Minnetonka,  MN  55343
Correspondent Contact MELANIE HESS
Regulation Number870.1650
Classification Product Code
DXT  
Date Received10/30/2015
Decision Date 02/04/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Clinical Trials NCT01976299
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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