OLYMPUS INSTRUMENT TRAY

Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

OLYMPUS WINTER & IBE GMBH

The following data is part of a premarket notification filed by Olympus Winter & Ibe Gmbh with the FDA for Olympus Instrument Tray.

Pre-market Notification Details

Device IDK110748
510k NumberK110748
Device Name:OLYMPUS INSTRUMENT TRAY
ClassificationSterilization Wrap Containers, Trays, Cassettes & Other Accessories
Applicant OLYMPUS WINTER & IBE GMBH 3500 CORPORATE PKWAY Center Valley,  PA  18034 -0610
ContactStacy Kluesner
CorrespondentStacy Kluesner
OLYMPUS WINTER & IBE GMBH 3500 CORPORATE PKWAY Center Valley,  PA  18034 -0610
Product CodeKCT  
CFR Regulation Number880.6850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-03-17
Decision Date2012-02-15
Summary:summary

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