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FDA 510(k) Application Details - DEN100026
Device Classification Name
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510(K) Number
DEN100026
Device Name
APTUS STEERABLE ENDOGUIDE WITH OBTURATOR, APTUS ENDOSTAPLE APPLIER WITH ENDOSTAPLE CASSETTE, APTUS ENDOSTAPLE CASSETTE
Applicant
APTUS ENDOSYSTEMS, INC.
777 N. PASTORIA AVE.
SUNNYVALE, CA 94085 US
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BURT GOODSON
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Regulation Number
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Classification Product Code
OTD
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Date Received
12/14/2010
Decision Date
11/21/2011
Decision
DENG -
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Type
Post-NSE
Reviewed By Third Party
N
Expedited Review
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