Saffron Fixation System— 510(k) K220420

Substantially Equivalent

Coloplast A/S

FDA 510(k) clearance K220420 for Saffron Fixation System, Substantially Equivalent on 2022-06-10. Applicant: Coloplast A/S.

Clearance details

Applicant: Coloplast A/S
Product code: Code PBQ
Advisory panel: Obstetrics/Gynecology
Date received: 2022-02-14
Decision date: 2022-06-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plymouth, MN, US

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