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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 K033201
Device Name LA500 BLUE LIGHT
Applicant
Apoza Enterprise Co., Ltd.
6 F,#657, Chuang Cheng Rd.
Hsin-Chuang City
Taipei Hsien,  TW 242
Applicant Contact SHIH MIN-TEH
Correspondent
Apoza Enterprise Co., Ltd.
6 F,#657, Chuang Cheng Rd.
Hsin-Chuang City
Taipei Hsien,  TW 242
Correspondent Contact SHIH MIN-TEH
Regulation Number872.6070
Classification Product Code
EBZ  
Date Received10/02/2003
Decision Date 12/02/2003
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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