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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 K833645
Device Name CONTRAST MEDIA INJECT. SET CMS
Applicant
Gish Biomedical, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Gish Biomedical, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number870.1650
Classification Product Code
DXT  
Date Received10/17/1983
Decision Date 04/17/1984
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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