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510(k) K202542

Device
Allura Vaginal Stent
Applicant
PMT Corporation
510(k) number
K202542
Product code
KXP  
Decision
Substantially Equivalent (SESE)
Decision date
2020-09-30
Date received
2020-09-02
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
Yes

Applicant Contact#

Contact
Matt Cree
Address
1500 Park Rd. Chanhassen MN US 55317 55317

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
K983045AMIELLEOwen Mumford USA, Inc.1998-11-25
K974479SILIMED VAGINAL STENTSilimed, LLC1998-08-05
K920633PESSARY FLEXIBLE SILICONE NICHOLSBioteque America, Inc.1995-11-08

Legacy Summary#

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FDA Review#

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