FDA 510(k) Application Details - K020902

Device Classification Name Suture, Nonabsorbable, Synthetic, Polyethylene

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510(K) Number K020902
Device Name Suture, Nonabsorbable, Synthetic, Polyethylene
Applicant SERRAL, S.A. DE C.V.
5251-18 JOHN TYLER HWY,
SUITE 167
WILLIAMSBURG, VA 23185 US
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Contact SCOTT HENDERSON
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Regulation Number 878.5000

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Classification Product Code GAT
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Date Received 03/20/2002
Decision Date 05/20/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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