Ellipse Supplemental Instrument Trays

Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

Ellipse Technologies, Incorporated

The following data is part of a premarket notification filed by Ellipse Technologies, Incorporated with the FDA for Ellipse Supplemental Instrument Trays.

Pre-market Notification Details

Device IDK151594
510k NumberK151594
Device Name:Ellipse Supplemental Instrument Trays
ClassificationSterilization Wrap Containers, Trays, Cassettes & Other Accessories
Applicant Ellipse Technologies, Incorporated 13900 Alton Parkway, Suite 123 Irvine,  CA  92618
ContactCora Sim
CorrespondentCora Sim
Ellipse Technologies, Incorporated 13900 Alton Parkway, Suite 123 Irvine,  CA  92618
Product CodeKCT  
CFR Regulation Number880.6850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-06-12
Decision Date2016-01-25
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00887517055507 K151594 000
00887517054302 K151594 000
00887517030801 K151594 000
00887517940339 K151594 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.