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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
Predetermined Change
Control Plan Authorized		 No
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