SYDNEY IVF HYALURONIDASE— 510(k) K023353

Substantially Equivalent

Cook Urological, Inc.

FDA 510(k) clearance K023353 for SYDNEY IVF HYALURONIDASE, Substantially Equivalent on 2002-12-20. 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: 2002-10-07
Decision date: 2002-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Spencer, IN, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.