FDA 510(k) Application Details - K081640

Device Classification Name Clip, Aneurysm

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510(K) Number K081640
Device Name Clip, Aneurysm
Applicant GIMMI GMBH
ONE SCANLAN PLAZA
SAINT PAUL, MN 55107 US
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Contact KEN BLAKE
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Regulation Number 882.5200

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Classification Product Code HCH
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Date Received 06/11/2008
Decision Date 05/06/2009
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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