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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 K800461
Device Name CENTRAL VENOUS PRESSURE CATHETER
Original Applicant
MEDICAL COMPONENTS, INC.
Regulation Number870.1200
Classification Product Code
DQO  
Date Received02/29/1980
Decision Date 03/12/1980
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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