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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Screening, Urine
510(k) Number K934759
Device Name CULTURIA MACCONKEY-MUG
Applicant
Clinical Convenience Products, Inc.
3802 Packers Ave.
P.O. Box 7773
Madison,  WI  53707
Applicant Contact GERALD TJERNAGEL
Correspondent
Clinical Convenience Products, Inc.
3802 Packers Ave.
P.O. Box 7773
Madison,  WI  53707
Correspondent Contact GERALD TJERNAGEL
Regulation Number866.2660
Classification Product Code
JXA  
Subsequent Product Code
JSI  
Date Received10/04/1993
Decision Date 09/09/1994
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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