PLANMED CYTOGUIDE

System, X-ray, Mammographic

PLANMED OY

The following data is part of a premarket notification filed by Planmed Oy with the FDA for Planmed Cytoguide.

Pre-market Notification Details

Device IDK973493
510k NumberK973493
Device Name:PLANMED CYTOGUIDE
ClassificationSystem, X-ray, Mammographic
Applicant PLANMED OY 362, BALM COURT Wood Dale,  IL  60191
ContactBob Pienkowski
CorrespondentBob Pienkowski
PLANMED OY 362, BALM COURT Wood Dale,  IL  60191
Product CodeIZH  
CFR Regulation Number892.1710 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-09-15
Decision Date1997-11-10

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