FDA 510(k) Application Details - K080972

Device Classification Name Staple, Implantable

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510(K) Number K080972
Device Name Staple, Implantable
Applicant ETHICON ENDO-SUGERY, LLC
4545 CREEK RD.
CINCINNATI, OH 45242 US
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Contact RUTH A WOOD
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Regulation Number 878.4750

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Classification Product Code GDW
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Date Received 04/04/2008
Decision Date 07/03/2008
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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