ETHICON ENDO-SURGERY 5MM LAPAROSCOPIC MULTI-FEED STAPLER

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 Ethicon Endo-surgery 5mm Laparoscopic Multi-feed Stapler.

Pre-market Notification Details

Device IDK102632
510k NumberK102632
Device Name:ETHICON ENDO-SURGERY 5MM LAPAROSCOPIC MULTI-FEED STAPLER
ClassificationStaple, Implantable
Applicant ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati,  OH  45242 -2839
ContactRenee Rowe
CorrespondentRenee Rowe
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 Received2010-09-13
Decision Date2010-10-07
Summary:summary

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