MODIFIED ENDOPATH ILS

Endoscopic Tissue Approximation Device

ETHICON ENDO-SURGERY, INC.

The following data is part of a premarket notification filed by Ethicon Endo-surgery, Inc. with the FDA for Modified Endopath Ils.

Pre-market Notification Details

Device IDK940967
510k NumberK940967
Device Name:MODIFIED ENDOPATH ILS
ClassificationEndoscopic Tissue Approximation Device
Applicant ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati,  OH  45242 -2839
ContactLorri Jones
CorrespondentLorri Jones
ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati,  OH  45242 -2839
Product CodeOCW  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-03-02
Decision Date1994-05-27

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