SUCCESS CECAL INTUBATION ASSIST, MODEL: 4100— 510(k) K080764

Name: FDA 510(k) clearance K080764
Creator: U.S. Food and Drug Administration
Published: 2008-05-06

Substantially Equivalent

Max Endoscopy, Inc.

FDA 510(k) clearance K080764 for SUCCESS CECAL INTUBATION ASSIST, MODEL: 4100, Substantially Equivalent on 2008-05-06. Applicant: Max Endoscopy, Inc.. Device class: 2.

Clearance details

Applicant: Max Endoscopy, Inc.
Product code: Code ODC
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2008-03-18
Decision date: 2008-05-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Macedonia, OH, US

Download summary PDF View on FDA.gov ↗

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