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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 K960364
Device Name CU-200 LIGHT CURE UNIT
Applicant
Rolence Enterprise Co. , Ltd.
226 Kong-Shieh-Sir Village
Chungli, Taiwan,  TW
Applicant Contact STERLING CHENG
Correspondent
Rolence Enterprise Co. , Ltd.
226 Kong-Shieh-Sir Village
Chungli, Taiwan,  TW
Correspondent Contact STERLING CHENG
Regulation Number872.6070
Classification Product Code
EBZ  
Date Received01/25/1996
Decision Date 04/15/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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