Cryotec— 510(k) K162051

Substantially Equivalent

Reprolife, Inc.

FDA 510(k) clearance K162051 for Cryotec, Substantially Equivalent on 2016-12-14. Applicant: Reprolife, Inc.. Device class: 2.

Clearance details

Applicant: Reprolife, Inc.
Product code: Product code MQK
Device class: Class 2
Regulation: 21 CFR 884.6160
Advisory panel: Obstetrics/Gynecology
Date received: 2016-07-25
Decision date: 2016-12-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shinjuku-Ku, JP

Download summary PDF View on FDA.gov ↗

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