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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 K963014
Device Name SIMON NITINOL FILTER/STRAIGHT LINE SYSTEM
Applicant
NITINOL MEDICAL TECHNOLOGIES, INC.
555 THIRTEENTH STREET, N.W.
WASHINGTON,  DC  20004 -1109
Applicant Contact SHERRIE COVAL-GOLDSMITH
Correspondent
NITINOL MEDICAL TECHNOLOGIES, INC.
555 THIRTEENTH STREET, N.W.
WASHINGTON,  DC  20004 -1109
Correspondent Contact SHERRIE COVAL-GOLDSMITH
Regulation Number870.3375
Classification Product Code
DTK  
Date Received08/02/1996
Decision Date 11/18/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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