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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
Applicant
Rmt Medical Technilogies, Inc.
1835 Market St.
Suite 200
Philadelphia,  PA  19103
Applicant Contact JANICE M HOGAN
Correspondent
Rmt Medical Technilogies, Inc.
1835 Market St.
Suite 200
Philadelphia,  PA  19103
Correspondent Contact JANICE M HOGAN
Regulation Number870.3375
Classification Product Code
DTK  
Date Received04/21/2008
Decision Date 05/07/2009
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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