FDA 510(k) Application Details - K072930

Device Classification Name Suture, Absorbable, Natural

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510(K) Number K072930
Device Name Suture, Absorbable, Natural
Applicant DEMETECH CORP.
3530 N.W. 115TH AVE.
MIAMI, FL 33178 US
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Contact A.J. DIMERCURIO
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Regulation Number 878.4830

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Classification Product Code GAL
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Date Received 10/16/2007
Decision Date 04/30/2008
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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