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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 K983739
Device Name OPTUM, INTRAORAL CAMERA SYSTEM
Applicant
Camsight, Inc.
11661 San Vicente Blvd.
Los Angeles,  CA  90049
Applicant Contact W.EDWARD JOHANSEN
Correspondent
Camsight, Inc.
11661 San Vicente Blvd.
Los Angeles,  CA  90049
Correspondent Contact W.EDWARD JOHANSEN
Regulation Number872.6640
Classification Product Code
EIA  
Date Received10/22/1998
Decision Date 01/19/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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