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FDA 510(k) Application Details - K051301
Device Classification Name
Staple, Implantable
More FDA Info for this Device
510(K) Number
K051301
Device Name
Staple, Implantable
Applicant
ETHICON ENDO-SURGERY, INC.
4545 CREEK RD.
CINCINNATI, OH 45242-2839 US
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Contact
KIMBERLY MCCOY
Other 510(k) Applications for this Contact
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
05/19/2005
Decision Date
08/30/2005
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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