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FDA 510(k) Application Details - K024275
Device Classification Name
Staple, Implantable
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510(K) Number
K024275
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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More FDA Info for this Product Code
Date Received
12/23/2002
Decision Date
03/14/2003
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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