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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 K081138
Device Name SAFEFLO VENA CAVA FILTER
Original Applicant
RMT MEDICAL TECHNILOGIES INC.
1835 market street
suite 200
philadelphia,  PA  19103
Original Contact janice m hogan
Regulation Number870.3375
Classification Product Code
DTK  
Date Received04/21/2008
Decision Date 05/07/2009
Decision substantially equivalent - with limitations (SU)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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