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FDA 510(k) Application Details - K091574
Device Classification Name
Suture, Nonabsorbable, Synthetic, Polyethylene
More FDA Info for this Device
510(K) Number
K091574
Device Name
Suture, Nonabsorbable, Synthetic, Polyethylene
Applicant
SUPPLIDORES UNIDOS INTERNACIONALES, S.A.
PO BOX 97-0132
COCONUT CREEK, FL 33067-2366 US
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Contact
VICTOR PEREIRA
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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
06/02/2009
Decision Date
10/09/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
FDA Source Information for K091574
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