FDA 510(k) Application Details - K031531

Device Classification Name Suture, Nonabsorbable, Synthetic, Polyamide

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510(K) Number K031531
Device Name Suture, Nonabsorbable, Synthetic, Polyamide
Applicant S & T AG
28438 BALLARD DR.
LAKE FOREST, IL 60045 US
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Contact BERNHARD TEITZ
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Regulation Number 878.5020

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Classification Product Code GAR
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Date Received 05/15/2003
Decision Date 09/23/2003
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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