FDA 510(k) Application Details - K060329

Device Classification Name Mesh, Surgical, Polymeric

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510(K) Number K060329
Device Name Mesh, Surgical, Polymeric
Applicant ENDOGUN MEDICAL SYSTEMS
C/O YORAM LEVY
31 HAAVODA STREET
BINYAMINA 30500 IL
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Contact YORAM LEVY
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Regulation Number 878.3300

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Classification Product Code FTL
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Date Received 02/09/2006
Decision Date 09/11/2006
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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