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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 K053376
Device Name CHUNG CHENG FAR INFRARED RAY HEALTHFUL LAMP (OR MEDICAL FIR RADIATOR), MODEL CH-8810
Applicant
CHUNG CHENG ELECTRIC HEATING CO., LTD.
2904 N. BOLDT DRIVE
FLAGSTAFF,  AZ  86001
Applicant Contact JENNIFER REICH
Correspondent
CHUNG CHENG ELECTRIC HEATING CO., LTD.
2904 N. BOLDT DRIVE
FLAGSTAFF,  AZ  86001
Correspondent Contact JENNIFER REICH
Regulation Number890.5500
Classification Product Code
ILY  
Date Received12/05/2005
Decision Date 02/16/2006
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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