PERFADEX WITH THAM— 510(k) K081997

Substantially Equivalent

Vitrolife Sweden AB

FDA 510(k) clearance K081997 for PERFADEX WITH THAM, Substantially Equivalent on 2008-10-09. Applicant: Vitrolife Sweden AB. Device class: 2.

Clearance details

Applicant: Vitrolife Sweden AB
Product code: Code MSB
Device class: Class 2
Regulation: 21 CFR 876.5880
Advisory panel: Gastroenterology, Urology
Date received: 2008-07-14
Decision date: 2008-10-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Kungsbacka, SE

Download summary PDF View on FDA.gov ↗

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