BIOPSY M

System, X-ray, Mammographic

SITCO, INC.

The following data is part of a premarket notification filed by Sitco, Inc. with the FDA for Biopsy M.

Pre-market Notification Details

Device IDK982049
510k NumberK982049
Device Name:BIOPSY M
ClassificationSystem, X-ray, Mammographic
Applicant SITCO, INC. 3456 N. RIDGE AVE. #100 Arlington Heights,  IL  60004
ContactRobert H Mccarthy
CorrespondentRobert H Mccarthy
SITCO, INC. 3456 N. RIDGE AVE. #100 Arlington Heights,  IL  60004
Product CodeIZH  
CFR Regulation Number892.1710 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-06-11
Decision Date1998-07-14
Summary:summary

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