FDA 510(k) Application Details - K140609

Device Classification Name Staple, Implantable

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510(K) Number K140609
Device Name Staple, Implantable
Applicant COVIDIEN
60 Middletown Ave
North Haven, CT 06473 US
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Contact CLARE SANTULLI
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Regulation Number 878.4750

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Classification Product Code GDW
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Date Received 03/10/2014
Decision Date 04/09/2014
Decision SESE - SUBST EQUIV
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



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