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
Code MQK
Device class
Class 2
Regulation
21 CFR 884.6160
Advisory panel
Obstetrics/Gynecology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Austin, TX, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.