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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 K912144
Device Name SIMON NITINOL FILTER, MODIFICATION
Applicant
Nitinol Medical Technologies, Inc.
101 Park Ave.
New York,  NY  10178
Applicant Contact LEONARD GORDON
Correspondent
Nitinol Medical Technologies, Inc.
101 Park Ave.
New York,  NY  10178
Correspondent Contact LEONARD GORDON
Regulation Number870.3375
Classification Product Code
DTK  
Date Received05/13/1991
Decision Date 10/17/1991
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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