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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Flame Photometry, Lithium
510(k) Number K934106
Device Name KODAK EKTACHEM DTSC II SLIDES (LI)
Applicant
Eastman Kodak Company
343 State St.
Rochester,  NY  14650
Applicant Contact BRADFPRD M SPRING
Correspondent
Eastman Kodak Company
343 State St.
Rochester,  NY  14650
Correspondent Contact BRADFPRD M SPRING
Regulation Number862.3560
Classification Product Code
JIH  
Date Received08/23/1993
Decision Date 04/25/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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