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FDA 510(k) Application Details - K090159

Device Classification Name Staple, Implantable

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510(K) Number K090159
Device Name Staple, Implantable
Applicant INCISIVE SURGICAL, INC.
14405 21ST AVE N.
SUITE 130
PLYMOUTH, MN US
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Contact JAMES PETERSON
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Regulation Number 878.4750

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Classification Product Code GDW
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Date Received 01/22/2009
Decision Date 02/06/2009
Decision SE - Substantially Equivalent
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review N



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