SYDNEY IVF PVP— 510(k) K031304

Substantially Equivalent

Cook Urological, Inc.

FDA 510(k) clearance K031304 for SYDNEY IVF PVP, Substantially Equivalent on 2004-03-23. Applicant: Cook Urological, Inc.. Device class: 2.

Clearance details

Applicant
Cook Urological, Inc.
Product code
Code MQL
Device class
Class 2
Regulation
21 CFR 884.6180
Advisory panel
Obstetrics/Gynecology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Spencer, IN, US
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