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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Spot-Film
510(k) Number K940386
Device Name KODAK AUTOMIXER III INTEGRATED, KODAK AUTOMIXER III 180 LP
Applicant
Eastman Kodak Company
343 State St.
Rochester,  NY  14650
Applicant Contact NORMAL GEIL
Correspondent
Eastman Kodak Company
343 State St.
Rochester,  NY  14650
Correspondent Contact NORMAL GEIL
Regulation Number892.1670
Classification Product Code
IXL  
Date Received01/26/1994
Decision Date 08/17/1994
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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