K180302

Substantially Equivalent

Guardia Access Malleable Obturator, Guardia Obturator, Soft-Pass Obturator, Soft-Trans Malleable Obturator, Guardia ETS Embryo-Tested Syringe, Flushing Catheter

Applicant: Cook Incorporated
Product code: MQF
Advisory panel: Obstetrics/Gynecology
Date received: 2018-02-02
Decision date: 2018-10-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bloomington, IN, US

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