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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 K842799
Device Name PERCUTANEOUS ANGIOSCOPE DELIVERY CATH
Applicant
AMERICAN EDWARDS LABORATORIES
803 N. Front St. Suite 3
mchenry,  IL  60050
Correspondent
AMERICAN EDWARDS LABORATORIES
803 N. Front St. Suite 3
mchenry,  IL  60050
Regulation Number870.1200
Classification Product Code
DQO  
Date Received07/17/1984
Decision Date 08/10/1984
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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