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

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..

Clearance details

Applicant: Mondeal North America, Inc.
Product code: Code OCZ
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

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