THS INSTRUMENT TRAY

Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

HOLOGIC, INC.

The following data is part of a premarket notification filed by Hologic, Inc. with the FDA for Ths Instrument Tray.

Pre-market Notification Details

Device IDK120947
510k NumberK120947
Device Name:THS INSTRUMENT TRAY
ClassificationSterilization Wrap Containers, Trays, Cassettes & Other Accessories
Applicant HOLOGIC, INC. 250 CAMPUS DRIVE Marlborough,  MA  01752
ContactSarah Fairfield
CorrespondentSarah Fairfield
HOLOGIC, INC. 250 CAMPUS DRIVE Marlborough,  MA  01752
Product CodeKCT  
CFR Regulation Number880.6850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-03-29
Decision Date2012-10-17
Summary:summary

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