Precision Ideal Eyes Arthroscopes

Arthroscope

Stryker

The following data is part of a premarket notification filed by Stryker with the FDA for Precision Ideal Eyes Arthroscopes.

Pre-market Notification Details

Device IDK183470
510k NumberK183470
Device Name:Precision Ideal Eyes Arthroscopes
ClassificationArthroscope
Applicant Stryker 5900 Optical Court San Jose,  CA  95138
ContactJessie Duong
CorrespondentJessie Duong
Stryker 5900 Optical Court San Jose,  CA  95138
Product CodeHRX  
CFR Regulation Number888.1100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-12-14
Decision Date2019-01-07
Summary:summary

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