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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 K963728
Device Name THE SPECIAL ELECTROMAGNETIC THERAPEUTIC APPARATUS
Applicant
China Chongqing Bashan Instrument Factory
307 W. Main St.
Suite 10
Alhambra,  CA  91801
Applicant Contact LU RAO
Correspondent
China Chongqing Bashan Instrument Factory
307 W. Main St.
Suite 10
Alhambra,  CA  91801
Correspondent Contact LU RAO
Regulation Number890.5500
Classification Product Code
ILY  
Date Received09/17/1996
Decision Date 12/12/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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