ACMI BIPOLAR RECTOSCOPE, MODEL EIWE-BR— 510(k) K021166

Name: FDA 510(k) clearance K021166
Creator: U.S. Food and Drug Administration
Published: 2002-05-09

Substantially Equivalent

Acmi-Circon Corporation

FDA 510(k) clearance K021166 for ACMI BIPOLAR RECTOSCOPE, MODEL EIWE-BR, Substantially Equivalent on 2002-05-09. Applicant: Acmi-Circon Corporation. Device class: 2.

Clearance details

Applicant: Acmi-Circon Corporation
Product code: Code FDC
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2002-04-11
Decision date: 2002-05-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Southborough, MA, US

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