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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drug Mixture Control Materials
510(k) Number K903189
Device Name KODATROL LIQUID CONTROL LEVELS I & II
Applicant
Eastman Kodak Company
343 State St.
Rochester,  NY  14650
Applicant Contact NORMAN H GEIL
Correspondent
Eastman Kodak Company
343 State St.
Rochester,  NY  14650
Correspondent Contact NORMAN H GEIL
Regulation Number862.3280
Classification Product Code
DIF  
Date Received07/19/1990
Decision Date 08/22/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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