CAMERA ENABLED PROBE

Arthroscope

TRICE MEDICAL, INC.

The following data is part of a premarket notification filed by Trice Medical, Inc. with the FDA for Camera Enabled Probe.

Pre-market Notification Details

Device IDK141119
510k NumberK141119
Device Name:CAMERA ENABLED PROBE
ClassificationArthroscope
Applicant TRICE MEDICAL, INC. 1000 CONTINENTAL DRIVE, SUITE 240 King Of Prussia,  PA  19406
ContactTiffini Diage
CorrespondentTiffini Diage
TRICE MEDICAL, INC. 1000 CONTINENTAL DRIVE, SUITE 240 King Of Prussia,  PA  19406
Product CodeHRX  
CFR Regulation Number888.1100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-04-30
Decision Date2014-07-29
Summary:summary

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