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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name electrode, electrosurgical, active, urological
510(k) Number K951863
Device Name ROLLER ELECTRODE
Applicant
OLYMPUS AMERICA, INC.
4 NEVADA DR.
LAKE SUCCESS,  NY  11042 -1179
Applicant Contact BARRY E SANDS
Correspondent
OLYMPUS AMERICA, INC.
4 NEVADA DR.
LAKE SUCCESS,  NY  11042 -1179
Correspondent Contact BARRY E SANDS
Regulation Number876.4300
Classification Product Code
FAS  
Subsequent Product Code
FJL  
Date Received04/21/1995
Decision Date 08/24/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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