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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name filter, intravascular, cardiovascular
510(k) Number K771046
Device Name VENA CAVA UMBRELLA FILTER, MODEL 7321
Applicant
EDWARDS LABORATORIES
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
EDWARDS LABORATORIES
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number870.3375
Classification Product Code
DTK  
Date Received06/10/1977
Decision Date 06/22/1977
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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