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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cassette, Radiographic Film
510(k) Number K040378
Device Name KODAK DIRECTVIEW CR CASSETTE/GP/15 X 30 CM, CATALOG# 8418253
Applicant
Eastman Kodak Company
343 State St.
Rochester,  NY  14650
Applicant Contact SUSAN PATE
Correspondent
Eastman Kodak Company
343 State St.
Rochester,  NY  14650
Correspondent Contact SUSAN PATE
Regulation Number892.1850
Classification Product Code
IXA  
Date Received02/17/2004
Decision Date 05/24/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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