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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Film Marking, Radiographic
510(k) Number K870565
Device Name KODAK X-OMATIC IDENT. CAMERA, MODELS 2 AND 2L
Applicant
Eastman Kodak Company
343 State St.
Rochester,  NY  14650
Applicant Contact GEIL, ESQ.
Correspondent
Eastman Kodak Company
343 State St.
Rochester,  NY  14650
Correspondent Contact GEIL, ESQ.
Regulation Number892.1640
Classification Product Code
JAC  
Date Received02/10/1987
Decision Date 02/26/1987
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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