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510(k) K883610

Device
LAKE FOLEY CATHETERIZATION TRAY
Applicant
LAKE MEDICAL PRODUCTS, INC.
510(k) number
K883610
Product code
FCN  
Decision
Substantially Equivalent (SESE)
Decision date
1988-10-12
Date received
1988-08-22
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
Third party reviewed
No

Applicant Contact#

Contact
ELI SCHACHET
Address
1145 Moog Dr. St. Louis MO US 63146 63146

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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
K922346FEMALE URINE SAMPLING DEVICEMentor Corp.1992-08-14
K890096BLADDER CYCLER CLOSED-SYSTEM URINARY DRAIN BAGMedical Inventors Corp., Inc.1989-07-14
K883886DOUBLE CLOSED URINARY DRAINAGE SYSTEMKnight Medical, Inc.1988-12-19
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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