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510(k) K883057

Device
Comfort Cath Male External Catheter
Applicant
SIERRA LABORATORIES, INC.
510(k) number
K883057
Product code
EYT
Decision
Substantially Equivalent (SESE)
Decision date
1988-08-02
Date received
1988-07-19
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
KLUG, PHD
Address
3520 S. Campbell Ave. P.O. Box 27005 Tucson AZ US 85726 85726

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
K883119VPI NON-ADHESIVE CONDOM CATHETERCook Urological, Inc.1988-08-02