MAMMOTOME MR BIOPSY SYSTEM

Instrument, Biopsy

ETHICON ENDO-SURGERY, INC.

The following data is part of a premarket notification filed by Ethicon Endo-surgery, Inc. with the FDA for Mammotome Mr Biopsy System.

Pre-market Notification Details

Device IDK042753
510k NumberK042753
Device Name:MAMMOTOME MR BIOPSY SYSTEM
ClassificationInstrument, Biopsy
Applicant ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati,  OH  45242 -2839
ContactCarol J Sprinkle
CorrespondentCarol J Sprinkle
ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati,  OH  45242 -2839
Product CodeKNW  
CFR Regulation Number876.1075 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-10-04
Decision Date2004-11-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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00841911100584 K042753 000
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00841911101017 K042753 000
00841911101000 K042753 000
00841911100638 K042753 000
00841911100621 K042753 000
00841911101796 K042753 000

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