QUANTUM WARP 10 LIGHT DELIVERY SYSTEM

Lamp, Infrared, Therapeutic Heating

QUANTUM DEVICES, INC.

The following data is part of a premarket notification filed by Quantum Devices, Inc. with the FDA for Quantum Warp 10 Light Delivery System.

Pre-market Notification Details

Device IDK032229
510k NumberK032229
Device Name:QUANTUM WARP 10 LIGHT DELIVERY SYSTEM
ClassificationLamp, Infrared, Therapeutic Heating
Applicant QUANTUM DEVICES, INC. PO BOX 848 Grayslake,  IL  60030
ContactMichele H Vovolka
Product CodeILY  
CFR Regulation Number890.5500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2003-07-21
Decision Date2003-09-12
Summary:summary

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