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510(k) K974479

Device
SILIMED VAGINAL STENT
Applicant
SILIMED, LLC.
510(k) number
K974479
Product code
KXP  
Decision
Substantially Equivalent (SESE)
Decision date
1998-08-05
Date received
1997-11-26
Regulation
884.3900
Classification name
Stent, Vaginal
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
E J SMITH
Address
P.O. Box 4341 Crofton MD US 21114 21114

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KXP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K202542Allura Vaginal StentPmt Corporation2020-09-30
K983045AMIELLEOwen Mumford USA, Inc.1998-11-25
K920633PESSARY FLEXIBLE SILICONE NICHOLSBioteque America, Inc.1995-11-08

Legacy Summary#

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FDA Review#

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