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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 K070514
Device Name ALN OPTIONAL VENA CAVA FILTER-FEMORAL APPROACH, JUGULAR APPROACH, BRACHIAL APPROACH, EXTRACTION KIT, PRECURVED EXTRACTIO
Applicant
ALN IMPLANTS CHIRURGICAUX
900 CIRCLE 75 PKWY.
SUITE 1240
ATLANTA,  GA  30339
Applicant Contact DAVE PARENTE
Correspondent
ALN IMPLANTS CHIRURGICAUX
900 CIRCLE 75 PKWY.
SUITE 1240
ATLANTA,  GA  30339
Correspondent Contact DAVE PARENTE
Regulation Number870.3375
Classification Product Code
DTK  
Date Received02/22/2007
Decision Date 01/30/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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