OMF ASP System

Driver, Wire, And Bone Drill, Manual


The following data is part of a premarket notification filed by Vha Dean with the FDA for Omf Asp System.

Pre-market Notification Details

Device IDK220648
510k NumberK220648
Device Name:OMF ASP System
ClassificationDriver, Wire, And Bone Drill, Manual
Applicant VHA DEAN 810 Vermont Ave NW Washington,  DC  20420
ContactBeth Ripley
CorrespondentLaura Gilmour
LG Strategies, LLC 2001 Parker Lane #122 Austin,  TX  78741
Product CodeDZJ  
CFR Regulation Number872.4120 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-03-07
Decision Date2022-08-11

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