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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 K880987
Device Name INJECTOR HANDLE WITH SYRINGE
Applicant
Applied Vascular Devices, Inc.
2740 S. Harbor, Suite K
Santa Ana,  CA  92704
Applicant Contact SAID S HILAL
Correspondent
Applied Vascular Devices, Inc.
2740 S. Harbor, Suite K
Santa Ana,  CA  92704
Correspondent Contact SAID S HILAL
Regulation Number870.1650
Classification Product Code
DXT  
Date Received03/08/1988
Decision Date 05/13/1988
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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