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510(k) K883119

Device
VPI NON-ADHESIVE CONDOM CATHETER
Applicant
COOK UROLOGICAL, INC.
510(k) number
K883119
Product code
EYT  
Decision
Substantially Equivalent (SESE)
Decision date
1988-08-02
Date received
1988-07-25
Regulation
876.5250
Classification name
Sheath, Corrugated Rubber, For Nonindwelling Catheter, Sterile
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
SUE SMITH
Address
1100 W. Morgan St. P.O. Box 227 Spencer IN US 47460 47460

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code EYT  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K934080URINARY DRAINAGE BAGKit Pak, Inc.1994-05-18
K935774CURITY FAST-CATH FEMALE CATHETER KITKendall Healthcare Products Co. Div.Of Tyco Health1994-04-11
K883057COMFORT CATH MALE EXTERNAL CATHETERSierra Laboratories, Inc.1988-08-02

Legacy Summary#

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FDA Review#

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