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FDA 510(k) Application Details - K013990
Device Classification Name
Suture, Nonabsorbable, Synthetic, Polyethylene
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510(K) Number
K013990
Device Name
Suture, Nonabsorbable, Synthetic, Polyethylene
Applicant
EDWARDS LIFESCIENCES, LLC.
ONE EDWARDS WAY
IRVINE, CA 92614 US
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Contact
LUCINDA STOCKERT
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Regulation Number
878.5000
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Classification Product Code
GAT
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More FDA Info for this Product Code
Date Received
12/03/2001
Decision Date
02/27/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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