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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Multi Format, Radiological
510(k) Number K860691
Device Name KODAK EKTASCAN VIDEO CAMERA & COMPACT VIDEO CAMERA
Applicant
Eastman Kodak Company
343 State St.
Rochester,  NY  14650
Applicant Contact PHILIP J HARTER
Correspondent
Eastman Kodak Company
343 State St.
Rochester,  NY  14650
Correspondent Contact PHILIP J HARTER
Regulation Number892.2040
Classification Product Code
LMC  
Date Received02/25/1986
Decision Date 03/13/1986
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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