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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name internal tissue marker
De Novo Number DEN130004
Device Name MOERAE SURGICAL MARKING PEN
Requester
MOERAE MATRIX, INC.
675 us highway 1
north brunswick,  NJ  08902
Contact robert j chin
Regulation Number878.4670
Classification Product Code
PDW  
Date Received05/06/2013
Decision Date 12/18/2014
Decision granted (DENG)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Post-NSE
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