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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name lamp, infrared, therapeutic heating
510(k) Number K081962
Device Name LAPEX BCS
Applicant
MERIDIAN CO., LTD.
PO BOX 7007
deerfield,  IL  60015
Applicant Contact daniel kamm
Correspondent
MERIDIAN CO., LTD.
PO BOX 7007
deerfield,  IL  60015
Correspondent Contact daniel kamm
Regulation Number890.5500
Classification Product Code
ILY  
Date Received07/09/2008
Decision Date 12/29/2008
Decision substantially equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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