FDA 510(k) Application Details - K033985

Device Classification Name Mesh, Surgical

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510(K) Number K033985
Device Name Mesh, Surgical
Applicant PM DEVICES, INC.
2135-13700 MAYFIELD PLACE
RICHMOND, BC V6V 2E4 CA
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Contact BRITTA DOMBOVARI
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Regulation Number 878.3300

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Classification Product Code FTM
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Date Received 12/23/2003
Decision Date 06/04/2004
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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