FDA 510(k) Application Details - K020804

Device Classification Name Staple, Implantable

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510(K) Number K020804
Device Name Staple, Implantable
Applicant UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
150 GLOVER AVE.
NORWALK, CT 06856 US
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Contact SARAH HUBENY
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Regulation Number 878.4750

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Classification Product Code GDW
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Date Received 03/12/2002
Decision Date 11/19/2002
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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