CYTOGUIDE FOR USE W/THE PHILMEDISYST MAMMODIAG UC

System, X-ray, Mammographic

PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.

The following data is part of a premarket notification filed by Philips Medical Systems North America, Inc. with the FDA for Cytoguide For Use W/the Philmedisyst Mammodiag Uc.

Pre-market Notification Details

Device IDK896609
510k NumberK896609
Device Name:CYTOGUIDE FOR USE W/THE PHILMEDISYST MAMMODIAG UC
ClassificationSystem, X-ray, Mammographic
Applicant PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. 710 BRIDGEPORT AVE. Shelton,  CT  06484
ContactWilliam G Mcmahon
CorrespondentWilliam G Mcmahon
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. 710 BRIDGEPORT AVE. Shelton,  CT  06484
Product CodeIZH  
CFR Regulation Number892.1710 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-08-09
Decision Date1990-01-31

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