MAMMOSITE CAVITY EVALUATION DEVICE

System, Applicator, Radionuclide, Remote-controlled

HOLOGIC, INC.

The following data is part of a premarket notification filed by Hologic, Inc. with the FDA for Mammosite Cavity Evaluation Device.

Pre-market Notification Details

Device IDK081179
510k NumberK081179
Device Name:MAMMOSITE CAVITY EVALUATION DEVICE
ClassificationSystem, Applicator, Radionuclide, Remote-controlled
Applicant HOLOGIC, INC. 250 CAMPUS DRIVE Marlborough,  MA  01752
ContactRandall J Covill
CorrespondentCasey Conry
UNDERWRITERS LABORATORIES, INC. 1285 WALT WHITMAN RD. Melville,  NY  11747
Product CodeJAQ  
CFR Regulation Number892.5700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2008-04-25
Decision Date2008-05-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
15420045505018 K081179 000

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