CULTURE DISH 40 MM, CULTURE DISH 60 MM, MICRO DROPLET CULTURE DISH, 5 WELL CULTURE DISH, CENTRE WELL DISH, ICSI DISH— 510(k) K123641

Name: FDA 510(k) clearance K123641
Creator: U.S. Food and Drug Administration
Published: 2013-07-03

Substantially Equivalent

Hertart

FDA 510(k) clearance K123641 for CULTURE DISH 40 MM, CULTURE DISH 60 MM, MICRO DROPLET CULTURE DISH, 5 WELL CULTURE DISH, CENTRE WELL DISH, ICSI DISH, Substantially Equivalent on 2013-07-03. Applicant: Hertart. Device class: 2.

Clearance details

Applicant: Hertart
Product code: Product code MQK
Device class: Class 2
Regulation: 21 CFR 884.6160
Advisory panel: Obstetrics/Gynecology
Date received: 2012-11-26
Decision date: 2013-07-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Greve, DK

Download summary PDF View on FDA.gov ↗

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