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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Digitizer, Image, Radiological
510(k) Number K971894
Device Name KODAK DIGITAL SCIENCE - DENTAL SCANNING SYSTEM
Applicant
EASTMAN KODAK COMPANY
343 STATE ST.
ROCHESTER,  NY  14650 -1131
Applicant Contact JUDITH A WALLACE
Correspondent
EASTMAN KODAK COMPANY
343 STATE ST.
ROCHESTER,  NY  14650 -1131
Correspondent Contact JUDITH A WALLACE
Regulation Number892.2030
Classification Product Code
LMA  
Date Received05/22/1997
Decision Date 08/20/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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