FDA.reportPublic FDA data

510(k) K082939

Device
COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400
Applicant
Cook Urological, Inc.
510(k) number
K082939
Product code
KNA
Decision
Substantially Equivalent (SESE)
Decision date
2009-09-03
Date received
2008-10-02
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
CINDY FOOTE
Address
750 Daniels Way Bloomington IN US 47404 47404

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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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
K971277SAFE-T-CLAMPTalon Medical, Ltd.1997-05-20