Mi-eye 3 Needlescope With Cannula, Mi-tablet 3

Arthroscope

Trice Medical, Inc.

The following data is part of a premarket notification filed by Trice Medical, Inc. with the FDA for Mi-eye 3 Needlescope With Cannula, Mi-tablet 3.

Pre-market Notification Details

Device IDK212556
510k NumberK212556
Device Name:Mi-eye 3 Needlescope With Cannula, Mi-tablet 3
ClassificationArthroscope
Applicant Trice Medical, Inc. 40 General Warren Blvd, Suite 100 Malvern,  PA  19355
ContactDavid Vancelette
CorrespondentDavid Vancelette
Trice Medical, Inc. 40 General Warren Blvd, Suite 100 Malvern,  PA  19355
Product CodeHRX  
CFR Regulation Number888.1100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-13
Decision Date2021-09-15

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.