CONTOUR TRANSTAR CURVED CUTTER STAPLER SET

Staple, Implantable

ETHICON ENDO-SURGERY, INC.

The following data is part of a premarket notification filed by Ethicon Endo-surgery, Inc. with the FDA for Contour Transtar Curved Cutter Stapler Set.

Pre-market Notification Details

Device IDK053631
510k NumberK053631
Device Name:CONTOUR TRANSTAR CURVED CUTTER STAPLER SET
ClassificationStaple, Implantable
Applicant ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati,  OH  45242 -2839
ContactWendy Turner
CorrespondentWendy Turner
ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati,  OH  45242 -2839
Product CodeGDW  
CFR Regulation Number878.4750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-12-29
Decision Date2006-01-30
Summary:summary

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