CRYOTOP— 510(k) K112695

Substantially Equivalent

Kitazato Biopharma Co;Ltd

FDA 510(k) clearance K112695 for CRYOTOP, Substantially Equivalent on 2012-12-12. Applicant: Kitazato Biopharma Co;Ltd. Device class: 2.

Clearance details

Applicant: Kitazato Biopharma Co;Ltd
Product code: Product code MQK
Device class: Class 2
Regulation: 21 CFR 884.6160
Advisory panel: Obstetrics/Gynecology
Date received: 2011-09-15
Decision date: 2012-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, 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.