FDA.reportPublic FDA data

510(k) K920633

Device
PESSARY FLEXIBLE SILICONE NICHOLS
Applicant
BIOTEQUE AMERICA, INC.
510(k) number
K920633
Product code
KXP  
Decision
Substantially Equivalent (SESE)
Decision date
1995-11-08
Date received
1992-02-12
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
DENNIS DORSEY
Address
340 E. Maple Ave. Suite 102 Langhorne PA US 19047 19047

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
K974479SILIMED VAGINAL STENTSilimed, LLC1998-08-05

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases