FDA 510(k) Application Details - K013749

Device Classification Name Staple, Implantable

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510(K) Number K013749
Device Name Staple, Implantable
Applicant ETHICON ENDO-SURGERY, INC.
4545 CREEK RD.
CINCINNATI, OH 45242-2839 US
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Contact DOUG KENTZ
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Regulation Number 878.4750

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Classification Product Code GDW
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Date Received 11/13/2001
Decision Date 02/11/2002
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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