FDA 510(k) Application Details - K024091

Device Classification Name Suture, Nonabsorbable, Silk

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510(K) Number K024091
Device Name Suture, Nonabsorbable, Silk
Applicant AUROLAB
6441 ENTERPRISE LN.
SUITE 214
MADISON, WI 53719 US
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Contact MICHAEL G PRICE
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Regulation Number 878.5030

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Classification Product Code GAP
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Date Received 12/11/2002
Decision Date 02/28/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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