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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 K894703
Device Name SIMON NITINOL FILTER
Applicant
NITINOL MEDICAL TECHNOLOGIES, INC.
7779 WILLOW GLEN RD.
LOS ANGLES,  CA  90046 -1610
Applicant Contact JACK REINSTEIN
Correspondent
NITINOL MEDICAL TECHNOLOGIES, INC.
7779 WILLOW GLEN RD.
LOS ANGLES,  CA  90046 -1610
Correspondent Contact JACK REINSTEIN
Regulation Number870.3375
Classification Product Code
DTK  
Date Received07/24/1989
Decision Date 04/20/1990
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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