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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K827889
Device Name KODAK KODAFLEX FILM
Applicant
Eastman Kodak Company
343 State St.
Rochester,  NY  14650
Correspondent
Eastman Kodak Company
343 State St.
Rochester,  NY  14650
Date Received08/12/1982
Decision Date 09/01/1982
Decision Substantially Equivalent (SESE)
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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