LAPEX BCS

Lamp, Infrared, Therapeutic Heating

MERIDIAN CO., LTD.

The following data is part of a premarket notification filed by Meridian Co., Ltd. with the FDA for Lapex Bcs.

Pre-market Notification Details

Device IDK081962
510k NumberK081962
Device Name:LAPEX BCS
ClassificationLamp, Infrared, Therapeutic Heating
Applicant MERIDIAN CO., LTD. PO BOX 7007 Deerfield,  IL  60015
ContactDaniel Kamm
CorrespondentDaniel Kamm
MERIDIAN CO., LTD. PO BOX 7007 Deerfield,  IL  60015
Product CodeILY  
CFR Regulation Number890.5500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-07-09
Decision Date2008-12-29
Summary:summary

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