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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 K901659
Device Name TITANIUM GREENFIELD(R) VENA CAVA FILTER W/HOOKS
Applicant
BOSTON SCIENTIFIC CORP.
480 PLEASANT ST.
P.O. BOX 7407
WATERTOWN,  MA  02272
Applicant Contact SAVIN, MD
Correspondent
BOSTON SCIENTIFIC CORP.
480 PLEASANT ST.
P.O. BOX 7407
WATERTOWN,  MA  02272
Correspondent Contact SAVIN, MD
Regulation Number870.3375
Classification Product Code
DTK  
Date Received04/10/1990
Decision Date 11/08/1990
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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