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510(k) K952527

Device
BALLOON UTERINE STENT
Applicant
COOK UROLOGICAL, INC.
510(k) number
K952527
Product code
KNA  
Decision
Substantially Equivalent (SESE)
Decision date
1996-01-02
Date received
1995-06-01
Regulation
884.4530
Classification name
Instrument, Manual, Specialized Obstetric-gynecologic
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
TAMMY BACON
Address
1100 W. Morgan St. P.O. Box 227 Spencer IN US 47460 47460

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KNA  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K130087PANPAC WORD/BARTHOLIN CATHETERPanpac Medical Corporation2014-01-10
K102141COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED)Cook Urological, Inc.2011-05-06
K093904GLENVEIGH VAGINAL TAMPONADE BALLOON CATHETERGlenveigh Surgical, LLC2010-04-14
K082939COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400Cook Urological, Inc.2009-09-03
K062438BAKRI POSTPARTUM BALLOON, MODEL J-SOS-100500Cook Ob/Gyn2006-10-27
K060289EPISTAT, V-STAT, MODELS EPISTAT-001-01, V-STAT-001-01Frontline Medical2006-07-07
K013597TAMPONADE UTERINE BALLOON CATHETER SETCook Ob/Gyn2002-04-17
K014248DND 202 MANUAL UROLOGICAL DIGITAL NEEDLE DRIVERUrogyn , Ltd.2002-03-21
K001590DND 101Urogyn , Ltd.2000-08-02
K990738DR. JAHANGER'S CUTTERM.S. Jahanger, MD1999-10-29
K990045BERACLAMP, MODEL BC-1Poamax LLC1999-05-24
K982464SCC-23 SAFETY CLAMP AND CUTTERWomen First Healthcare, Inc.1998-08-11
K980717UROMED SLING KITUromed Corp.1998-05-22
K980237GYNEX ENDOSPECULUMGynex Corp.1998-04-08
K972013NATIONAL MEDICAL HEALTHCARE CUSTOM OB/GYN KITS, TRAYS, OR PACKSNational Healthcare Mfg. Corp.1997-08-26

Legacy Summary#

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FDA Review#

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