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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 K043558
Device Name XINFENG HEAT LAMPS, MODELS, CQ-27,CQ-36, CQ-55, CQ-55A
Applicant
CHONGQING XINFENG MEDICAL INSTRUMENTS CO., LTD.
1800 CENTURY PARK E, STE 600
CENTURY CITY,  CA  90067
Applicant Contact GEORGE SU
Correspondent
CHONGQING XINFENG MEDICAL INSTRUMENTS CO., LTD.
1800 CENTURY PARK E, STE 600
CENTURY CITY,  CA  90067
Correspondent Contact GEORGE SU
Regulation Number890.5500
Classification Product Code
ILY  
Date Received12/27/2004
Decision Date 06/06/2005
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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