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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 K860842
Device Name ANGIOJECT
Applicant
Target Therapeutics
2100 S. Sepulveda Blvd.
Los Angeles,  CA  90025
Applicant Contact MARIE DANIELS
Correspondent
Target Therapeutics
2100 S. Sepulveda Blvd.
Los Angeles,  CA  90025
Correspondent Contact MARIE DANIELS
Regulation Number870.1650
Classification Product Code
DXT  
Date Received03/04/1986
Decision Date 04/23/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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