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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 K955396
Device Name STAINLESS STEEL GREENFIELD VENA CAVA FILTER WITH 12F FLEXCARRIER INTRODUCTER SYSTEM
Applicant
Boston Scientific Corp
One Boston Scientific Pl.
Natick,  MA  01760 -1537
Applicant Contact LAURA MONDANO
Correspondent
Boston Scientific Corp
One Boston Scientific Pl.
Natick,  MA  01760 -1537
Correspondent Contact LAURA MONDANO
Regulation Number870.3375
Classification Product Code
DTK  
Date Received11/24/1995
Decision Date 02/09/1996
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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