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510(k) K983045

Device
AMIELLE
Applicant
Owen Mumford USA, Inc.
510(k) number
K983045
Product code
KXP  
Decision
Substantially Equivalent (SESE)
Decision date
1998-11-25
Date received
1998-09-01
Regulation
884.3900
Classification name
Stent, Vaginal
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
ROBERT E SHAW
Address
849 Pickens Industrial Dr. Suite 14 Marietta GA US 30062 30062

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KXP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K202542Allura Vaginal StentPmt Corporation2020-09-30
K974479SILIMED VAGINAL STENTSilimed, LLC1998-08-05
K920633PESSARY FLEXIBLE SILICONE NICHOLSBioteque America, Inc.1995-11-08

Legacy Summary#

summary

FDA Review#

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