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510(k) K950176

Device
PREMIE U-BAG URINE SPECIMEN COLLECTOR
Applicant
HOLLISTER, INC.
510(k) number
K950176
Product code
FOC  
Decision
Substantially Equivalent (SESE)
Decision date
1995-02-07
Date received
1995-01-17
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
Summary
Third party reviewed
No

Applicant Contact#

Contact
JOSEPH S TOKARZ
Address
2000 Hollister Dr. Libertyville IL US 60048 60048

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FOC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K943752RIMECO MIDSTREAM URINE COLLECTORRimeco Products, Inc.1994-11-01
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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