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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name clip, implantable
510(k) Number K091987
Device Name ANASTOCLIP MODELS 4001-01, 4000-02, 4000-03, 4000-04, 4004-01, 4004-02, ANASTOCLIP
Applicant
LEMAITRE VASCULAR, INC.
63 2ND AVENUE
BURLINGTON,  MA  01803
Applicant Contact ERIN E DALY
Correspondent
LEMAITRE VASCULAR, INC.
63 2ND AVENUE
BURLINGTON,  MA  01803
Correspondent Contact ERIN E DALY
Regulation Number878.4300
Classification Product Code
FZP  
Subsequent Product Code
HBT  
Date Received07/02/2009
Decision Date 04/23/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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