WHEELCHAIR CUSHIONS

Cushion, Flotation

DIGNICARE

The following data is part of a premarket notification filed by Dignicare with the FDA for Wheelchair Cushions.

Pre-market Notification Details

Device IDK851814
510k NumberK851814
Device Name:WHEELCHAIR CUSHIONS
ClassificationCushion, Flotation
Applicant DIGNICARE 10 WEST STREETSBORO RD. P.O. BOX 1496 Hudson,  OH  44236
ContactWilliam Mcgraw
CorrespondentWilliam Mcgraw
DIGNICARE 10 WEST STREETSBORO RD. P.O. BOX 1496 Hudson,  OH  44236
Product CodeKIC  
CFR Regulation Number890.3175 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-04-26
Decision Date1985-07-09

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