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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Activator, Ultraviolet, For Polymerization
510(k) Number K061695
Device Name LED PROLUX 770
Applicant
Peng Lim Enterprise Co., Ltd.
67 Hwa Rong Rd., 2nd Floor ,
Ku Shan Dist.
Kaohsiung,  TW
Applicant Contact C.S. WANG
Correspondent
Peng Lim Enterprise Co., Ltd.
67 Hwa Rong Rd., 2nd Floor ,
Ku Shan Dist.
Kaohsiung,  TW
Correspondent Contact C.S. WANG
Regulation Number872.6070
Classification Product Code
EBZ  
Date Received06/15/2006
Decision Date 09/14/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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