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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 K940489
Device Name SIMON NITINOL FILTER
Applicant
NITINOL MEDICAL TECHNOLOGIES, INC.
374 CONGRESS STREET, SUITE 605
BOSTON,  MA  02210
Applicant Contact STEPHEN J KLESHINSKI
Correspondent
NITINOL MEDICAL TECHNOLOGIES, INC.
374 CONGRESS STREET, SUITE 605
BOSTON,  MA  02210
Correspondent Contact STEPHEN J KLESHINSKI
Regulation Number870.3375
Classification Product Code
DTK  
Date Received01/25/1994
Decision Date 08/09/1994
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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