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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Film, Radiographic
510(k) Number K800901
Device Name KODAK EKTASPEED DENTAL X-RAY FILM
Applicant
Eastman Kodak Company
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Eastman Kodak Company
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number892.1840
Classification Product Code
IWZ  
Date Received04/18/1980
Decision Date 05/20/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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