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FDA 510(k) Application Details - DEN090007
Device Classification Name
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510(K) Number
DEN090007
Device Name
BIO-SEAL LUNG BIOPSY TRACT SYSTEM
Applicant
ANGIOTECH
1618 STATION STREET
VANCOUVER, BC V6A 1B6 CA
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TRUDY ESTRIDGE
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Regulation Number
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Classification Product Code
OMT
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Date Received
04/17/2009
Decision Date
12/19/2012
Decision
DENG -
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Type
Post-NSE
Reviewed By Third Party
N
Expedited Review
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