Endo Keeper— 510(k) K152598

Substantially Equivalent

Nelis

FDA 510(k) clearance K152598 for Endo Keeper, Substantially Equivalent on 2016-03-17. Applicant: Nelis. Device class: 2.

Clearance details

Applicant: Nelis
Product code: Code OTJ
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2015-09-11
Decision date: 2016-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bucheon, KR

Download summary PDF View on FDA.gov ↗

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