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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 K821816
Device Name ANGIOGRAPHIC CATHETER
Applicant
MEDI-TECH, INC.
Regulation Number870.1200
Classification Product Code
DQO  
Date Received06/21/1982
Decision Date 08/24/1982
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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