EEVA DISH (WITH 12 MICROWELLS)— 510(k) K141663

Substantially Equivalent

Auxogyn, Inc.

FDA 510(k) clearance K141663 for EEVA DISH (WITH 12 MICROWELLS), Substantially Equivalent on 2014-07-22. Applicant: Auxogyn, Inc.. Device class: 2.

Clearance details

Applicant: Auxogyn, Inc.
Product code: Product code MQK
Device class: Class 2
Regulation: 21 CFR 884.6160
Advisory panel: Obstetrics/Gynecology
Date received: 2014-06-23
Decision date: 2014-07-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Menlo Park, CA, US

Download summary PDF View on FDA.gov ↗

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