DYNASTY U1-33 AGM

Components, Wheelchair

FOLEY & LARDNER

The following data is part of a premarket notification filed by Foley & Lardner with the FDA for Dynasty U1-33 Agm.

Pre-market Notification Details

Device IDK942311
510k NumberK942311
Device Name:DYNASTY U1-33 AGM
ClassificationComponents, Wheelchair
Applicant FOLEY & LARDNER 3000 K STREET, N.W. SUITE 500 Washington,  DC  20007 -5109
ContactIlene K Gotts
CorrespondentIlene K Gotts
FOLEY & LARDNER 3000 K STREET, N.W. SUITE 500 Washington,  DC  20007 -5109
Product CodeKNN  
CFR Regulation Number890.3920 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-05-13
Decision Date1994-11-07

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