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510(k) K943752

Device
RIMECO MIDSTREAM URINE COLLECTOR
Applicant
RIMECO PRODUCTS, INC.
510(k) number
K943752
Product code
FOC  
Decision
Substantially Equivalent (SESE)
Decision date
1994-11-01
Date received
1994-08-02
Regulation
876.5250
Classification name
Bag, Urine Collection, Newborn
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
VALENTIN RIBIC
Address
7603 - B9 First Pl. Dr. Oakwood Village OH US 44146 44146

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FOC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K950176PREMIE U-BAG URINE SPECIMEN COLLECTORHollister, Inc.1995-02-07
K911329BARD(R) SURECATCH PEDIATRIC URINE COLLECT DEVICEC.R. Bard, Inc.1991-05-28
K771368PORTABLE INFANT VENTILATORCavitron Corp.1977-08-04

Legacy Summary#

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FDA Review#

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