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510(k) K922346

Device
FEMALE URINE SAMPLING DEVICE
Applicant
MENTOR CORP.
510(k) number
K922346
Product code
FCN  
Decision
Substantially Equivalent (SESE)
Decision date
1992-08-14
Date received
1992-05-19
Regulation
876.5250
Classification name
Urinary Drainage Collection Kit, For Indwelling Catheter
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
BYRON H WICKETT
Address
5425 Hollister Ave. Santa Barbara CA US 93111 93111

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FCN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K951443STANDARD FOLEY SYSTEM PAKTrinity Laboratories, Inc.1995-06-15
K945258CATCO URINARY COLLECTION KITCatco Medical, Inc.1995-02-16
K915166MICROCYCLERMedical Inventors Corp., Inc.1994-09-07
K890096BLADDER CYCLER CLOSED-SYSTEM URINARY DRAIN BAGMedical Inventors Corp., Inc.1989-07-14
K883886DOUBLE CLOSED URINARY DRAINAGE SYSTEMKnight Medical, Inc.1988-12-19
K883610LAKE FOLEY CATHETERIZATION TRAYLake Medical Products, Inc.1988-10-12
K780134URINARY DRAINAGE MONITORING SYSTEMMedical Devices, Inc.1978-02-02
K772133URINE SPECIMEN COLLECTING DEVICEKendall Research Center1977-11-28
K771210UROGARD URINARY DRAINAGE BAGTerumo America, Inc.1977-07-11

Legacy Summary#

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FDA Review#

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