E-Z-EM ENDOSCOPIC CO2 REGULATOR— 510(k) K053008

Substantially Equivalent

E-Z-Em, Inc.

FDA 510(k) clearance K053008 for E-Z-EM ENDOSCOPIC CO2 REGULATOR, Substantially Equivalent on 2005-12-27. Applicant: E-Z-Em, Inc..

Clearance details

Applicant: E-Z-Em, Inc.
Product code: Code FCX
Advisory panel: Gastroenterology, Urology
Date received: 2005-10-26
Decision date: 2005-12-27
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Westbury, NY, US

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