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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bag, Urine Collection, Newborn
510(k) Number K943752
Device Name RIMECO MIDSTREAM URINE COLLECTOR
Applicant
Rimeco Products, Inc.
7603 - B9 First Pl. Dr.
Oakwood Village,  OH  44146
Applicant Contact VALENTIN RIBIC
Correspondent
Rimeco Products, Inc.
7603 - B9 First Pl. Dr.
Oakwood Village,  OH  44146
Correspondent Contact VALENTIN RIBIC
Regulation Number876.5250
Classification Product Code
FOC  
Date Received08/02/1994
Decision Date 11/01/1994
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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