INNOVO— 510(k) K192357

Substantially Equivalent

Atlantic Therapeutics, Ltd.

FDA 510(k) clearance K192357 for INNOVO, Substantially Equivalent on 2020-01-16. Applicant: Atlantic Therapeutics, Ltd.. Device class: 2.

Clearance details

Applicant: Atlantic Therapeutics, Ltd.
Product code: Code QAJ
Device class: Class 2
Regulation: 21 CFR 876.5330
Advisory panel: Gastroenterology, Urology
Date received: 2019-08-29
Decision date: 2020-01-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Galway, IE

Download summary PDF View on FDA.gov ↗

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