ACMI BIPOLAR RECTOSCOPE, MODEL EIWE-BR


Device Classification Name

resectoscope, working element

510(k) Number K021166
Device Name ACMI BIPOLAR RECTOSCOPE, MODEL EIWE-BR
Original Applicant
ACMI-CIRCON CORPORATION
136 turpike rd.
southborough, 
MA 
01772

Original Contact john a delucia
Regulation Number 876.1500
Classification Product Code
FDC  
Subsequent Product Code
FBO  
Date Received 04/11/2002
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