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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Resectoscope, Working Element
510(k) Number K021166
Device Name ACMI BIPOLAR RECTOSCOPE, MODEL EIWE-BR
Applicant
Acmi-Circon Corporation
136 Turpike Rd.
Southborough,  MA  01772
Applicant Contact JOHN A DELUCIA
Correspondent
Acmi-Circon Corporation
136 Turpike Rd.
Southborough,  MA  01772
Correspondent Contact JOHN A DELUCIA
Regulation Number876.1500
Classification Product Code
FDC  
Subsequent Product Code
FBO  
Date Received04/11/2002
Decision Date 05/09/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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