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510(k) K935774

Device
CURITY FAST-CATH FEMALE CATHETER KIT
Applicant
KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH
510(k) number
K935774
Product code
EYT  
Decision
Substantially Equivalent - Kit With Drugs (SEKD)
Decision date
1994-04-11
Date received
1993-12-03
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
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
DAVID A OLSON
Address
15 Hampshire St. Mansfield MA US 02048 02048

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
K883057COMFORT CATH MALE EXTERNAL CATHETERSierra Laboratories, Inc.1988-08-02
K883119VPI NON-ADHESIVE CONDOM CATHETERCook Urological, Inc.1988-08-02

Legacy Summary#

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FDA Review#

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