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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
Other 510(k) Applications for this Contact
Regulation Number
878.4830
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Classification Product Code
GAL
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More FDA Info for this Product Code
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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