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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 K904994
Device Name CLOSED SYSTEM FLUSH SET
Applicant
Argon Medical Corp.
1445 Flat Creek Rd.
P.O. Box 1970
Athens,  TX  75751
Applicant Contact GAIL DOHERTY
Correspondent
Argon Medical Corp.
1445 Flat Creek Rd.
P.O. Box 1970
Athens,  TX  75751
Correspondent Contact GAIL DOHERTY
Regulation Number870.1650
Classification Product Code
DXT  
Date Received11/07/1990
Decision Date 01/15/1991
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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