ESI MODEL MS-103

Retractor, Self-retaining, For Neurosurgery

ELECTRICAL SYSTEMS DIV.

The following data is part of a premarket notification filed by Electrical Systems Div. with the FDA for Esi Model Ms-103.

Pre-market Notification Details

Device IDK885120
510k NumberK885120
Device Name:ESI MODEL MS-103
ClassificationRetractor, Self-retaining, For Neurosurgery
Applicant ELECTRICAL SYSTEMS DIV. 8918 TESORO DR. SUITE 120 San Antonio,  TX  78217
ContactPatrick T Thayer
CorrespondentPatrick T Thayer
ELECTRICAL SYSTEMS DIV. 8918 TESORO DR. SUITE 120 San Antonio,  TX  78217
Product CodeGZT  
CFR Regulation Number882.4800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-12-12
Decision Date1990-01-19

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