MICROMARK II TISSUE MARKER,MODEL C1535

Marker, Radiographic, Implantable

ETHICON ENDO-SURGERY, INC.

The following data is part of a premarket notification filed by Ethicon Endo-surgery, Inc. with the FDA for Micromark Ii Tissue Marker,model C1535.

Pre-market Notification Details

Device IDK013413
510k NumberK013413
Device Name:MICROMARK II TISSUE MARKER,MODEL C1535
ClassificationMarker, Radiographic, Implantable
Applicant ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati,  OH  45242 -2839
ContactGeorgia C Abernathy
CorrespondentGeorgia C Abernathy
ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati,  OH  45242 -2839
Product CodeNEU  
CFR Regulation Number878.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-10-15
Decision Date2001-12-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10841911100376 K013413 000
10841911100369 K013413 000

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