FDA 510(k) Application Details - K091574

Device Classification Name Suture, Nonabsorbable, Synthetic, Polyethylene

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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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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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