MONDEAL ENDOSCOPIC TISSUE RECESSION AND RELEASE SYSTEM— 510(k) K072684

Name: FDA 510(k) clearance K072684
Creator: U.S. Food and Drug Administration
Published: 2008-01-04

Substantially Equivalent

Mondeal North America, Inc.

FDA 510(k) clearance K072684 for MONDEAL ENDOSCOPIC TISSUE RECESSION AND RELEASE SYSTEM, Substantially Equivalent on 2008-01-04. Applicant: Mondeal North America, Inc.. Device class: 2.

Clearance details

Applicant: Mondeal North America, Inc.
Product code: Code OCZ
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2007-09-21
Decision date: 2008-01-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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