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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 K993123
Device Name QK-WIDE BAND SPECTRUM THERAPEUTIC APPARATUS, MODELS CO1A, CO1B, CO1C, CO1D, CO2A, CO2B
Applicant
United Pacific Co., Ltd.
219 S. Raymond Ave.
Alhambra,  CA  91801
Applicant Contact DANIEL YE HUA
Correspondent
United Pacific Co., Ltd.
219 S. Raymond Ave.
Alhambra,  CA  91801
Correspondent Contact DANIEL YE HUA
Regulation Number890.5500
Classification Product Code
ILY  
Date Received09/20/1999
Decision Date 12/17/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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