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510(k) K003380

Device
BIOTEQUE VAGINAL DILATOR
Applicant
BIOTEQUE AMERICA, INC.
510(k) number
K003380
Product code
HDX  
Decision
Substantially Equivalent (SESE)
Decision date
2001-01-29
Date received
2000-10-31
Regulation
884.3900
Classification name
Dilator, 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
DENIS DORSEY
Address
340 E. Maple Ave., #204-C 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 HDX  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K241748Intimate Rose Vaginal DilatorsPlus EV Holdings Dba Intimate Rose2024-08-14
K233689Hope&Her Vaginal DilatorsLujena, Inc.2024-05-02
K222492Hope&Her Vaginal DilatorsLujena, Inc.2023-06-27
K231430Intimate Rose Vaginal DilatorsPlus EV Holdings Dba Intimate Rose2023-06-07
K220035Milli Vaginal DilatorMaterna Medical2023-02-27
K211959Milli Vaginal DilatorMaterna Medical2021-12-01
K130273PANPAC VAGINAL DILATORSPanpac Medical Corporation2013-08-08
K071754NEO-VAGINA SURGERY SET AND ACCESSORIESKARL STORZ Endoscopy-America, Inc.2009-01-07

Legacy Summary#

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FDA Review#

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