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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 K901235
Device Name GREENFIELD VENA CAVA FILTER W/19.5 FR INTRODUCER
Applicant
BOSTON SCIENTIFIC CORP.
480 PLEASANT ST.
P.O. BOX 7407
watertown,  MA  02272
Applicant Contact michael a savin,md
Correspondent
BOSTON SCIENTIFIC CORP.
480 PLEASANT ST.
P.O. BOX 7407
watertown,  MA  02272
Correspondent Contact michael a savin,md
Regulation Number870.3375
Classification Product Code
DTK  
Date Received03/14/1990
Decision Date 10/09/1990
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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