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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Percutaneous Retrieval
510(k) Number K102484
Device Name SEQURE SNARE SYSTEM
Applicant
Lifetech Scientific (Shenzhen) Co., Ltd.
Langshan 2nd St.
Nanshan District
Shenzhen,  CN 518057
Applicant Contact SHI XIAOLI
Correspondent
Dekra Certification B.V
Utrechtseweg 310
Arnhem,  NL NL-6812 AR
Correspondent Contact ROBERT VAN BOXTEL
Regulation Number870.5150
Classification Product Code
MMX  
Date Received08/30/2010
Decision Date 11/09/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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