PACE SAVER LITTLE JUNIOR (MODIFICATION)

Vehicle, Motorized 3-wheeled

BURKE MOBILITY PRODUCTS

The following data is part of a premarket notification filed by Burke Mobility Products with the FDA for Pace Saver Little Junior (modification).

Pre-market Notification Details

Device IDK954974
510k NumberK954974
Device Name:PACE SAVER LITTLE JUNIOR (MODIFICATION)
ClassificationVehicle, Motorized 3-wheeled
Applicant BURKE MOBILITY PRODUCTS P.O. BOX 1064 Mission,  KS  66222
ContactDuwayne Kramer
CorrespondentDuwayne Kramer
BURKE MOBILITY PRODUCTS P.O. BOX 1064 Mission,  KS  66222
Product CodeINI  
CFR Regulation Number890.3800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-10-25
Decision Date1996-03-19

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