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FDA 510(k) Application Details - K102028
Device Classification Name
Suture, Nonabsorbable, Synthetic, Polyethylene
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510(K) Number
K102028
Device Name
Suture, Nonabsorbable, Synthetic, Polyethylene
Applicant
NEOTRACT, INC.
4473 WILLOW ROAD
SUITE 100
PLEASANTON, CA 94588 US
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Contact
KEVIN F MACDONALD
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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
07/19/2010
Decision Date
08/04/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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