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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 absorbable lung biopsy plug
De Novo Number DEN090007
510(K) Number K082438
Device Name BIO-SEAL LUNG BIOPSY TRACT SYSTEM
Requester
ANGIOTECH
1618 station street
vancouver, bc,  CA v6a 1b6
Contact trudy estridge
Regulation Number878.4755
Classification Product Code
OMT  
Date Received04/17/2009
Decision Date 12/19/2012
Decision granted (DENG)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee Anesthesiology
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Post-NSE
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