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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 K090487
Device Name DISPOSABLE ANGIOGRAPHIC SYRINGES FOR USE WITH NEMOTO ANGIOGRAPHIC POWER, MODEL SY-125, C855-5150
Applicant
Coeur, Inc.
704 Cadet Ct.
Lebanon,  TN  37087
Applicant Contact DEBRA MANNING
Correspondent
Coeur, Inc.
704 Cadet Ct.
Lebanon,  TN  37087
Correspondent Contact DEBRA MANNING
Regulation Number870.1650
Classification Product Code
DXT  
Date Received02/25/2009
Decision Date 10/19/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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