ARM THROUGH FOR WHEELCHAIR BK-6458-01

Components, Wheelchair

FRED SAMMONS, INC.

The following data is part of a premarket notification filed by Fred Sammons, Inc. with the FDA for Arm Through For Wheelchair Bk-6458-01.

Pre-market Notification Details

Device IDK823637
510k NumberK823637
Device Name:ARM THROUGH FOR WHEELCHAIR BK-6458-01
ClassificationComponents, Wheelchair
Applicant FRED SAMMONS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKNN  
CFR Regulation Number890.3920 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-12-06
Decision Date1983-01-21

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