SHOWER CHAIRS;BED/STRETCHER;LINEN & UTILITY CART

Stretcher, Wheeled

LUMEX, INC.

The following data is part of a premarket notification filed by Lumex, Inc. with the FDA for Shower Chairs;bed/stretcher;linen & Utility Cart.

Pre-market Notification Details

Device IDK895740
510k NumberK895740
Device Name:SHOWER CHAIRS;BED/STRETCHER;LINEN & UTILITY CART
ClassificationStretcher, Wheeled
Applicant LUMEX, INC. 100 SPENCE ST. Bay Shore,  NY  11706 -2290
ContactWarren Wartell
CorrespondentWarren Wartell
LUMEX, INC. 100 SPENCE ST. Bay Shore,  NY  11706 -2290
Product CodeFPO  
CFR Regulation Number880.6910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-09-26
Decision Date1990-02-22

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