FDA 510(k) Application Details - K141041

Device Classification Name

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510(K) Number K141041
Device Name APTUS HELI-FX ANCILLARY ENDOANCHOR CASSETTE
Applicant APTUS ENDOSYSTEMS
271 GIBRALTAR DR
SUNNYVALE, CA 94089-0000 US
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Contact BURT GOODSON
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Regulation Number

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Classification Product Code OTD
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Date Received 04/23/2014
Decision Date 05/16/2014
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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