ENDOGATOR ADVANTAGE IRRIGATION PUMP— 510(k) K113119

Substantially Equivalent

Byrne Medical, Inc.

FDA 510(k) clearance K113119 for ENDOGATOR ADVANTAGE IRRIGATION PUMP, Substantially Equivalent on 2012-04-27. Applicant: Byrne Medical, Inc..

Clearance details

Applicant: Byrne Medical, Inc.
Product code: Code OCX
Advisory panel: Gastroenterology, Urology
Date received: 2011-10-21
Decision date: 2012-04-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

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