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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Operative Dental
510(k) Number K040691
Device Name INTRA ORAL CAMERA SYSTEM & ACCESSORIES, MODEL WIN-100D
Applicant
Win-Us Technology Co., Ltd.
1308 Morningside Park Dr.
Alpharetta,  GA  30022
Applicant Contact JAY MANSOUR
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Regulation Number872.6640
Classification Product Code
EIA  
Date Received03/17/2004
Decision Date 03/23/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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