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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Subsystem, Proportioning
510(k) Number K850756
Device Name AUTO-D AUTOMATIC DISINFECTION ACCESS/ATTACHMENTS
Applicant
Travenol Laboratories, S.A.
Deerfield,  IL  60015
Applicant Contact JULIA MEYER
Correspondent
Travenol Laboratories, S.A.
Deerfield,  IL  60015
Correspondent Contact JULIA MEYER
Regulation Number876.5820
Classification Product Code
FKR  
Date Received02/25/1985
Decision Date 03/20/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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