TILT SEATING SYSTEM

Components, Wheelchair

LABAC SYSTEMS, INC.

The following data is part of a premarket notification filed by Labac Systems, Inc. with the FDA for Tilt Seating System.

Pre-market Notification Details

Device IDK923366
510k NumberK923366
Device Name:TILT SEATING SYSTEM
ClassificationComponents, Wheelchair
Applicant LABAC SYSTEMS, INC. 8955 SOUTH RIDGELINE BOULEVARD Highlands Ranch,  CO  80126
ContactPeter Zeeb
CorrespondentPeter Zeeb
LABAC SYSTEMS, INC. 8955 SOUTH RIDGELINE BOULEVARD Highlands Ranch,  CO  80126
Product CodeKNN  
CFR Regulation Number890.3920 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-07-08
Decision Date1993-02-12

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