OLYMPUS STERILIZATION TRAYS

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 Sterilization Trays.

Pre-market Notification Details

Device IDK033222
510k NumberK033222
Device Name:OLYMPUS STERILIZATION TRAYS
ClassificationSterilization Wrap Containers, Trays, Cassettes & Other Accessories
Applicant OLYMPUS WINTER & IBE GMBH TWO CORPORATE CENTER DR. Melville,  NY  11747 -3157
ContactTina Steffanie-oak
CorrespondentTina Steffanie-oak
OLYMPUS WINTER & IBE GMBH TWO CORPORATE CENTER DR. Melville,  NY  11747 -3157
Product CodeKCT  
CFR Regulation Number880.6850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-10-03
Decision Date2004-08-02
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04042761077125 K033222 000
04042761030236 K033222 000
04042761030229 K033222 000
04042761029933 K033222 000
04042761029766 K033222 000
04042761029674 K033222 000
04042761028844 K033222 000
04042761009652 K033222 000
04042761009645 K033222 000
04042761030243 K033222 000
04042761030250 K033222 000
04042761066969 K033222 000
04042761063241 K033222 000
04042761051248 K033222 000
04042761035361 K033222 000
04042761030885 K033222 000
04042761030304 K033222 000
04042761030298 K033222 000
04042761030267 K033222 000
04042761009560 K033222 000

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