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510(k) K943752

RIMECO MIDSTREAM URINE COLLECTOR by Rimeco Products, Inc. — Product Code FOC

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: November 1, 1994
Date Received: August 2, 1994
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Bag, Urine Collection, Newborn
Device Class: Class II
Regulation Number: 876.5250
Review Panel: GU
Submission Type