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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 K991503
Device Name SACRED CRANE TDP LAMP, MODELS CQ-27, CQ-12, CQ-36
Applicant
UNITED PACIFIC CO., LTD.
219 SOUTH RAYMOND AVE.
ALHAMBRA,  CA  91801
Applicant Contact DANIEL YE HUA
Correspondent
UNITED PACIFIC CO., LTD.
219 SOUTH RAYMOND AVE.
ALHAMBRA,  CA  91801
Correspondent Contact DANIEL YE HUA
Regulation Number890.5500
Classification Product Code
ILY  
Date Received04/29/1999
Decision Date 07/28/1999
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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