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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, intravascular, diagnostic
510(k) Number K800741
Device Name CENTRAL VEIN CATHETERIZATION KIT
Applicant
MEDICAL COMPONENTS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
MEDICAL COMPONENTS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number870.1200
Classification Product Code
DQO  
Date Received04/03/1980
Decision Date 04/16/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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