FDA 510(k) Application Details - K060520

Device Classification Name Mesh, Surgical, Polymeric

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510(K) Number K060520
Device Name Mesh, Surgical, Polymeric
Applicant PROXY BIOMEDICAL LTD.
P.O. BOX 560
STILLWATER, MN 55082 US
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Contact ELAINE DUNCAN
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Regulation Number 878.3300

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Classification Product Code FTL
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Date Received 02/27/2006
Decision Date 03/28/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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