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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name suture, nonabsorbable, synthetic, polyethylene
510(k) Number K013990
Device Name LIFESTITCH SUTURING DEVICE
Applicant
EDWARDS LIFESCIENCES, LLC.
ONE EDWARDS WAY
IRVINE,  CA  92614
Applicant Contact LUCINDA STOCKERT
Correspondent
EDWARDS LIFESCIENCES, LLC.
ONE EDWARDS WAY
IRVINE,  CA  92614
Correspondent Contact LUCINDA STOCKERT
Regulation Number878.5000
Classification Product Code
GAT  
Date Received12/03/2001
Decision Date 02/27/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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