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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cephalometer
510(k) Number K896099
Device Name DIGIGRAPH DIAGNOSTIC WORK/STATION
Applicant
Dolphin Imaging Systems
24841 Ave. Tibbetts
Valencia,  CA  91355
Applicant Contact TOM HAZEN
Correspondent
Dolphin Imaging Systems
24841 Ave. Tibbetts
Valencia,  CA  91355
Correspondent Contact TOM HAZEN
Regulation Number872.1830
Classification Product Code
EAG  
Date Received10/20/1989
Decision Date 01/31/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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