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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 K880877
Device Name CONTRAST INJECTION DEVICE
Applicant
Med-West, Inc.
P.O. Box 26851
Salt Lake City,  UT  84126
Applicant Contact DAVID C BEATTIE
Correspondent
Med-West, Inc.
P.O. Box 26851
Salt Lake City,  UT  84126
Correspondent Contact DAVID C BEATTIE
Regulation Number870.1650
Classification Product Code
DXT  
Date Received03/01/1988
Decision Date 05/31/1988
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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