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FDA 510(k) Application Details - K962258
Device Classification Name
Stapler, Surgical
More FDA Info for this Device
510(K) Number
K962258
Device Name
Stapler, Surgical
Applicant
ETHICON ENDO-SURGERY, INC.
4545 CREEK RD.
CINCINNATI, OH 45242-2839 US
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Contact
MELISSA WALKER, M.S., R.A.C.
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Regulation Number
878.4800
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Classification Product Code
GAG
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More FDA Info for this Product Code
Date Received
06/12/1996
Decision Date
09/11/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
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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