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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 K043306
Device Name SKYLARK INFRARED PHOTON STIMULATOR, MODELS, SD-956IR AND SD-100IR
Applicant
SKYLARK DEVICE & SYSTEMS CO., LTD
4F, 34, SEC. 3,
CHUNG SHAN NORTH RD.
TAIPEI,  TW 104
Applicant Contact BETTY CHIEN
Correspondent
SKYLARK DEVICE & SYSTEMS CO., LTD
4F, 34, SEC. 3,
CHUNG SHAN NORTH RD.
TAIPEI,  TW 104
Correspondent Contact BETTY CHIEN
Regulation Number890.5500
Classification Product Code
ILY  
Date Received12/01/2004
Decision Date 06/06/2005
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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