FDA.report

510(k) K040817

Device
POPSPEK DISPOSABLE ADJUSTABLE VAGINAL SPECULUM
Applicant
Advanced Urological Developments
510(k) number
K040817
Product code
HIB
Decision
Substantially Equivalent (SESE)
Decision date
2004-06-22
Date received
2004-03-30
Regulation
884.4530
Classification name
Speculum, Vaginal, Nonmetal
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
GERMAN BORODULIN
Address
485 Dartmouth Ave. San Carlos CA US 94070 94070

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF not indicated by FDA · openFDA JSON

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