PureSet Tray

Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

Nobel Biocare AB

The following data is part of a premarket notification filed by Nobel Biocare Ab with the FDA for Pureset Tray.

Pre-market Notification Details

Device IDK181075
510k NumberK181075
Device Name:PureSet Tray
ClassificationSterilization Wrap Containers, Trays, Cassettes & Other Accessories
Applicant Nobel Biocare AB BOX 5190, SE-402 26, Vastra Hamngatan 1 Goteborg,  SE Se-411 17
ContactCharlemagne Chua
CorrespondentCharlemagne Chua
Nobel Biocare USA, LLC 22715 Savi Ranch Parkway Yorba Linda,  CA  92887
Product CodeKCT  
CFR Regulation Number880.6850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-04-24
Decision Date2018-09-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07332747149982 K181075 000
07332747149999 K181075 000
07332747150001 K181075 000
07332747150018 K181075 000
07332747169072 K181075 000
07332747169089 K181075 000
07332747169065 K181075 000
07332747169034 K181075 000
07332747169041 K181075 000
07332747169058 K181075 000
07332747149975 K181075 000
07332747149968 K181075 000

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