FDA 510(k) Application Details - K150840

Device Classification Name Clip, Implantable

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510(K) Number K150840
Device Name Clip, Implantable
Applicant ETHICON ENDO-SURGERY, LLC
475 CALLE C SUITE 202
GUAYNABO, PR 00969 US
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Contact Marjorie Medina
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Regulation Number 878.4300

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Classification Product Code FZP
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Date Received 03/30/2015
Decision Date 09/10/2015
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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