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510(k) K964219

Device
ZIP CONDOM CATHETER
Applicant
GOULTER MEDICAL, INC.
510(k) number
K964219
Product code
EYZ  
Decision
Substantially Equivalent (SESE)
Decision date
1997-08-11
Date received
1996-10-22
Regulation
876.5250
Classification name
System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
DAVID W SCHLERF
Address
1000 Burnett Ave., Suite 450 Concord CA US 94520 94520

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code EYZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K961906UNI-GARD QUIK CATH(SIZES 8 FRENCH THROUGH 18)UG 10008,10010,10012,10014,10016,10018Spectrum Medsystems Corp.1996-11-19
K952780URINARY GEL DRAINAGE SYSTEMP.A.M., Inc.1995-12-12
K951597URINARY DRAINAGE BAGKey Medical Services, Inc.1995-08-04
K942753ONE STEP SPECIMEN COLLECTOR/TRANSPORT CONTAINERResearched, Novel Medical Devices (Rn/Md)1994-11-02
K933126COMFORTCARE SYSTEMPatsy J. Trisler, J.D.1994-02-25
K930556NIGHT URINARY DRAINAGE BEDSIDE BAGEzmt Valve Co., Inc.1993-05-14
K896695DYNA-FLO URINARY DRAINAGE BAGMedline Industries, Inc.1990-05-02
K901000URO TEX URINALSSierra Laboratories, Inc.1990-03-26
K890465CLOSED SYSTEM URINARY DRAINAGE BAGCypress Medical Products, Ltd.1989-05-23
K891178TECNOL SECURE-ALL TUBE HOLDERTecnol New Jersey Wound Care, Inc.1989-05-23
K882714URINARY DRAIN BAG, LSL CAT. NO. 1425 AND 1450Lsl Industries, Inc.1989-01-31
K780267CATH TRAY W/OUT CATHETERLatex Ind., Inc.1978-02-24
K772113URINARY DRAINAGE BAG 2D9017Travenol Laboratories, S.A.1977-11-16

Legacy Summary#

summary

FDA Review#

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