ENDO SMART BOTTLE, RINSE AND INSUFFLATION SYSTEM— 510(k) K140753

Name: FDA 510(k) clearance K140753
Creator: U.S. Food and Drug Administration
Published: 2014-07-15

Substantially Equivalent

Medivators

FDA 510(k) clearance K140753 for ENDO SMART BOTTLE, RINSE AND INSUFFLATION SYSTEM, Substantially Equivalent on 2014-07-15. Applicant: Medivators. Device class: 2.

Clearance details

Applicant: Medivators
Product code: Code OCX
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2014-03-26
Decision date: 2014-07-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

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