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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Culture Media, Selective And Differential
510(k) Number K864764
Device Name CULTURIA MACCONKEY-MUG/CLED SYSTEMS
Applicant
Clinical Convenience Products, Inc.
P.O. Box 7773
Madison,  WI  53707
Applicant Contact TODD STYKA
Correspondent
Clinical Convenience Products, Inc.
P.O. Box 7773
Madison,  WI  53707
Correspondent Contact TODD STYKA
Regulation Number866.2360
Classification Product Code
JSI  
Date Received12/05/1986
Decision Date 12/29/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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